Trial Outcomes & Findings for Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies (NCT NCT00307125)
NCT ID: NCT00307125
Last Updated: 2015-03-23
Results Overview
Data were analyzed for 653 participants from the screening phase of the study. This outcome looked at the number of kidney transplant recipients that developed de novo HLA antibodies (anti-HLA Ab) post-transplant. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
757 participants
Primary outcome timeframe
During screening window of 3-60 months post kidney transplant
Results posted on
2015-03-23
Participant Flow
N=757 subjects were enrolled in the screening phase (Stage 1: Screening) of the study and followed for development of de novo anti-HLA antibodies for up to 60 months post-kidney (renal) transplant.N=22 subjects from the screening cohort were enrolled in the treatment phase. Refer to Detailed Description and Eligibility Sections for more details.
From the screening cohort, N=22 subjects were enrolled in the treatment phase of the study (Stage 2: Pilot Study). Refer to Detailed Description and Eligibility Sections for more details.
Participant milestones
| Measure |
Screening Phase
Kidney (renal) transplant recipients with no detectable anti-human leukocyte antigen (HLA) antibodies prior to transplant. Participants were screened for the development of anti-HLA antibodies once every 3 months up to 36 months post-transplantation and yearly thereafter until Month 60.
|
Pilot Phase-Rituximab Plus Immunosuppression
Adult Dosing (Subjects \> 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
Pilot Phase-Placebo Plus Immunosuppression
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|---|
|
Screening Phase
STARTED
|
757
|
0
|
0
|
|
Screening Phase
COMPLETED
|
303
|
0
|
0
|
|
Screening Phase
NOT COMPLETED
|
454
|
0
|
0
|
|
Pilot Phase
STARTED
|
0
|
15
|
7
|
|
Pilot Phase
COMPLETED
|
0
|
13
|
6
|
|
Pilot Phase
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Screening Phase
Kidney (renal) transplant recipients with no detectable anti-human leukocyte antigen (HLA) antibodies prior to transplant. Participants were screened for the development of anti-HLA antibodies once every 3 months up to 36 months post-transplantation and yearly thereafter until Month 60.
|
Pilot Phase-Rituximab Plus Immunosuppression
Adult Dosing (Subjects \> 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
Pilot Phase-Placebo Plus Immunosuppression
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|---|
|
Screening Phase
Adverse Event
|
1
|
0
|
0
|
|
Screening Phase
Protocol Violation
|
27
|
0
|
0
|
|
Screening Phase
Lost to Follow-up
|
87
|
0
|
0
|
|
Screening Phase
Death
|
10
|
0
|
0
|
|
Screening Phase
Withdrawal by Subject
|
77
|
0
|
0
|
|
Screening Phase
Physician Decision
|
26
|
0
|
0
|
|
Screening Phase
Sponsor Decision
|
4
|
0
|
0
|
|
Screening Phase
Study Terminated
|
17
|
0
|
0
|
|
Screening Phase
Graft Loss
|
3
|
0
|
0
|
|
Screening Phase
Graft Failure
|
8
|
0
|
0
|
|
Screening Phase
Follow-up period ended on Dec 31, 2011
|
83
|
0
|
0
|
|
Screening Phase
Scheduling issues/Non-compliance
|
55
|
0
|
0
|
|
Screening Phase
Moved or transferred facilities
|
34
|
0
|
0
|
|
Screening Phase
Received Pancreas Transplant
|
8
|
0
|
0
|
|
Screening Phase
Ineligible for pilot
|
4
|
0
|
0
|
|
Screening Phase
Try to get pregnant
|
1
|
0
|
0
|
|
Screening Phase
Developed acute leukemia
|
1
|
0
|
0
|
|
Screening Phase
Metastatic colon cancer
|
1
|
0
|
0
|
|
Screening Phase
Malignancy
|
1
|
0
|
0
|
|
Screening Phase
PAK
|
1
|
0
|
0
|
|
Screening Phase
Ineligible
|
1
|
0
|
0
|
|
Screening Phase
Screen Error
|
1
|
0
|
0
|
|
Screening Phase
Sample of Anti-HLA Ab was not obtained
|
1
|
0
|
0
|
|
Screening Phase
AMR and treated with rituximab
|
1
|
0
|
0
|
|
Screening Phase
Coronary artery bypass
|
1
|
0
|
0
|
|
Pilot Phase
Lost to Follow-up
|
0
|
1
|
0
|
|
Pilot Phase
Withdrawal by Subject
|
0
|
1
|
1
|
Baseline Characteristics
Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies
Baseline characteristics by cohort
| Measure |
Pilot Phase-Rituximab Plus Immunosuppression
n=15 Participants
Adult Dosing (Subjects \> 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
Pilot Phase-Placebo Plus Immunosuppression
n=7 Participants
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 19.5 • n=99 Participants
|
49.0 years
STANDARD_DEVIATION 15.0 • n=107 Participants
|
43.8 years
STANDARD_DEVIATION 18.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
7 participants
n=107 Participants
|
22 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During screening window of 3-60 months post kidney transplantPopulation: Screening sample
Data were analyzed for 653 participants from the screening phase of the study. This outcome looked at the number of kidney transplant recipients that developed de novo HLA antibodies (anti-HLA Ab) post-transplant. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection.
Outcome measures
| Measure |
Screening Phase
n=653 Participants
Participants who were analyzed during the screening phase/stage of the study
|
Pilot Phase-Placebo Plus Immunosuppression
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|
|
During Screening Phase: Incidence of Alloantibody Development
|
79 participants
|
—
|
PRIMARY outcome
Timeframe: During screening window of 3-60 months post kidney transplantPopulation: Screening sample
Data were analyzed for 653 participants from the screening phase of the study. Of these, 79 (12%) developed de novo HLA-antibodies (anti-HLA Ab). This outcome looks at the average length of time (interval) from post kidney transplant until development of alloantibody. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection
Outcome measures
| Measure |
Screening Phase
n=653 Participants
Participants who were analyzed during the screening phase/stage of the study
|
Pilot Phase-Placebo Plus Immunosuppression
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|
|
During Screening Phase: Timing of Alloantibody Development
|
16.2 Months
Standard Deviation 9.9
|
—
|
PRIMARY outcome
Timeframe: 1 year post treatment initiationPopulation: Intent-to-treat
Number of participants with 50% decrease in circulating anti-HLA antibodies at any time within the first 12 months post kidney transplant by LuminexTM Beads Method. Luminex assays for quantitation and detection of cytokine and signal transduction proteins. Presence of circulating antibodies is indicative of the transplant recipient's immune system responding to the transplanted organ as a foreign object or infection.
Outcome measures
| Measure |
Screening Phase
n=15 Participants
Participants who were analyzed during the screening phase/stage of the study
|
Pilot Phase-Placebo Plus Immunosuppression
n=7 Participants
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|
|
Number of Participants With 50 Percent (%) Decrease in Circulating Anti-Human Leukocyte Antigen (HLA) Antibodies
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 months post treatment initiationPopulation: Intent-to-treat
Number of participant deaths within 12 months post treatment initiation
Outcome measures
| Measure |
Screening Phase
n=15 Participants
Participants who were analyzed during the screening phase/stage of the study
|
Pilot Phase-Placebo Plus Immunosuppression
n=7 Participants
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|
|
Number of Deaths 12 Months Post Treatment Initiation
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 year post treatment initiationPopulation: Intent-to-treat
Number of participants with graft loss, defined as the need for dialysis for greater than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure within 12 month post treatment initiation
Outcome measures
| Measure |
Screening Phase
n=15 Participants
Participants who were analyzed during the screening phase/stage of the study
|
Pilot Phase-Placebo Plus Immunosuppression
n=7 Participants
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|
|
Number of Participants Experiencing Graft Loss 12 Months Post Treatment Initiation
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 year post treatment initiationPopulation: Intent-to-treat
Number of participants with PTLD within 12 month post treatment initiation. Diagnosis of PTLD was made by B cell proliferation after therapeutic immunosuppression.
Outcome measures
| Measure |
Screening Phase
n=15 Participants
Participants who were analyzed during the screening phase/stage of the study
|
Pilot Phase-Placebo Plus Immunosuppression
n=7 Participants
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|
|
Number of Participants Experiencing Biopsy-proven Post-Transplant Lymphoproliferative Disease (PTLD)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 year post treatment initiationPopulation: Intent-to-treat
Number of participants with loss of PTC C4d staining on kidney (renal) biopsy within 12 months post treatment initiation. PTC C4d staining on biopsy indicates organ rejection.
Outcome measures
| Measure |
Screening Phase
n=15 Participants
Participants who were analyzed during the screening phase/stage of the study
|
Pilot Phase-Placebo Plus Immunosuppression
n=7 Participants
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|
|
Number of Participants Experiencing Loss of Peritubular Capillary (PTC) C4d Staining on Kidney Biopsy
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 year post treatment initiationPopulation: Intent-to-treat
Number of participants with viral replication of CMV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of viral replication is indicative of active CMV infection.
Outcome measures
| Measure |
Screening Phase
n=15 Participants
Participants who were analyzed during the screening phase/stage of the study
|
Pilot Phase-Placebo Plus Immunosuppression
n=7 Participants
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|
|
Number of Participants With Viral Replication of Cytomegalovirus (CMV)
Positive
|
3 participants
|
2 participants
|
|
Number of Participants With Viral Replication of Cytomegalovirus (CMV)
Negative
|
12 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 1 year post treatment initiationPopulation: Intent-to-treat
Number of participants with positive viral replication of EBV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of EBV viral replication is indicative of active infection.
Outcome measures
| Measure |
Screening Phase
n=15 Participants
Participants who were analyzed during the screening phase/stage of the study
|
Pilot Phase-Placebo Plus Immunosuppression
n=7 Participants
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|
|
Number of Participants With Evidence of Viral Replication of Epstein-Barr Virus (EBV)
Positive
|
7 participants
|
3 participants
|
|
Number of Participants With Evidence of Viral Replication of Epstein-Barr Virus (EBV)
Negative
|
8 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 1 year post treatment initiationPopulation: Intent-to-treat
Number of participants with viral replication of BKV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of viral replication is indicative of a BKV infection. Polyomavirus BK is a significant pathogen in transplant recipients.
Outcome measures
| Measure |
Screening Phase
n=15 Participants
Participants who were analyzed during the screening phase/stage of the study
|
Pilot Phase-Placebo Plus Immunosuppression
n=7 Participants
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|
|
Number of Participants With Viral Replication of Polyomavirus (BKV)
Positive
|
0 participants
|
0 participants
|
|
Number of Participants With Viral Replication of Polyomavirus (BKV)
Negative
|
15 participants
|
7 participants
|
Adverse Events
Pilot Phase-Rituximab Plus Immunosuppression
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Pilot Phase-Placebo Plus Immunosuppression
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pilot Phase-Rituximab Plus Immunosuppression
n=15 participants at risk
Adult Dosing (Subjects \> 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
Pilot Phase-Placebo Plus Immunosuppression
n=7 participants at risk
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|
|
Gastrointestinal disorders
Duodenal fistula
|
0.00%
0/15 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
14.3%
1/7 • Number of events 1 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
|
General disorders
Infusion related reaction
|
6.7%
1/15 • Number of events 1 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
0.00%
0/7 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
|
Immune system disorders
Transplant rejection
|
6.7%
1/15 • Number of events 1 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
0.00%
0/7 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
|
Infections and infestations
Chlamydial pelvic inflammatory disease
|
6.7%
1/15 • Number of events 1 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
0.00%
0/7 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
0.00%
0/7 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
14.3%
1/7 • Number of events 1 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
6.7%
1/15 • Number of events 1 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
0.00%
0/7 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
Other adverse events
| Measure |
Pilot Phase-Rituximab Plus Immunosuppression
n=15 participants at risk
Adult Dosing (Subjects \> 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
Pilot Phase-Placebo Plus Immunosuppression
n=7 participants at risk
Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Number of events 4 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
14.3%
1/7 • Number of events 1 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.7%
1/15 • Number of events 1 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
14.3%
1/7 • Number of events 1 • From kidney (renal) transplant to the end of study
Adverse events methods: * Observing the participant * Questioning the participant, which should be done in an objective manner. * Receiving an unsolicited complaint from the participant. * An abnormal value or result from a clinical or laboratory evaluation.
|
Additional Information
Director, Clinical Research Operations Program (CROP)
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place