Trial Outcomes & Findings for Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation (NCT NCT01178216)
NCT ID: NCT01178216
Last Updated: 2018-10-26
Results Overview
This trial is designed to determine if Rituximab + IVIG can improve rates of transplantation for highly-HLA sensitized DD candidates on the UNOS waiting list over a 9M period of time after completion of treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
9 month
Results posted on
2018-10-26
Participant Flow
From 2013 - 2017, Highly Sensitized (HS) patients with calculated panel reactive antibodies (CPRA)\>50% underwent desensitization while awaiting kidney transplantation
Participant milestones
| Measure |
Rituxan
All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.
Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation
Baseline characteristics by cohort
| Measure |
Rituxan
n=41 Participants
All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.
Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present.
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|---|---|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=99 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
48 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 9 monthThis trial is designed to determine if Rituximab + IVIG can improve rates of transplantation for highly-HLA sensitized DD candidates on the UNOS waiting list over a 9M period of time after completion of treatment.
Outcome measures
| Measure |
Rituxan
n=39 Participants
All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.
Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present.
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|---|---|
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Number of Patients That Underwent Transplantation
|
32 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 32 patients were successfully transplanted during the study, of 39 total participants.
Graft survival in study participants
Outcome measures
| Measure |
Rituxan
n=32 Participants
All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.
Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present.
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|---|---|
|
Number of Patients With Allograft Survival
|
28 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Donor specific antibodies (DSAs) assessed in transplanted population with DSA at time of transplant (32/39 patients transplanted during study, 23/32 with DSA at time of transplant)
Number of patients with a reduction in anti-HLA antibodies.
Outcome measures
| Measure |
Rituxan
n=23 Participants
All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.
Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present.
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|---|---|
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Reduction in Anti-HLA Antibodies
|
76 percentage of patients
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SECONDARY outcome
Timeframe: 12 monthsPopulation: 32 patients were successfully transplanted during the study, of 39 total participants. Only those who were transplanted were assessed for this endpoint.
Number of rejection episodes in study participants
Outcome measures
| Measure |
Rituxan
n=32 Participants
All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.
Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present.
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|---|---|
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Number of Acute Rejection Episodes
|
15 rejection episodes
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SECONDARY outcome
Timeframe: 12 monthsInfection rate in study participants
Outcome measures
| Measure |
Rituxan
n=39 Participants
All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.
Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present.
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|---|---|
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Number of Patients Reporting a Serious Infection
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsAdverse effects in study participants
Outcome measures
| Measure |
Rituxan
n=39 Participants
All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.
Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present.
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|---|---|
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Number of Adverse Events, Toxicity Assessments
|
14 events
|
Adverse Events
Rituxan
Serious events: 14 serious events
Other events: 20 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Rituxan
n=39 participants at risk
All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.
Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present.
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|---|---|
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Infections and infestations
Fungal Infection
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Nervous system disorders
Parietal Cystic Lesion
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Infections and infestations
Bacterial Infection
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary Incontinence
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Cyst in Left Kidney
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
7.7%
3/39 • Number of events 3 • 1 year
|
|
Cardiac disorders
Hypertension
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Allograft Thrombosis
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
General disorders
Hemorrhagic Shock
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Nervous system disorders
Fever
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Mild Hydronephrosis
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary Artery Disease
|
2.6%
1/39 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Bleeding from Incision Site
|
2.6%
1/39 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Rituxan
n=39 participants at risk
All study patients will receive Rituxan 1g on day 15 from start of desensitization and either 3M or 6M post transplant depending on the presence of DSA.
Rituxan: Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present.
|
|---|---|
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Nervous system disorders
Headache
|
17.9%
7/39 • Number of events 7 • 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
5.1%
2/39 • Number of events 2 • 1 year
|
|
Cardiac disorders
Hypertension
|
15.4%
6/39 • Number of events 6 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.3%
4/39 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Edema
|
7.7%
3/39 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
4/39 • Number of events 4 • 1 year
|
|
Skin and subcutaneous tissue disorders
Itching
|
12.8%
5/39 • Number of events 5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Itchy or Sore Throat
|
10.3%
4/39 • Number of events 4 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place