Trial Outcomes & Findings for Combination Drug Therapy Followed by Single Drug Steroid Free Therapy to Prevent Organ Rejection in Kidney Transplantation (NCT NCT00076570)
NCT ID: NCT00076570
Last Updated: 2013-10-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
3 years
Results posted on
2013-10-16
Participant Flow
Totally 31 patients were enrolled during August 2002 to October 2006 at NIH clinical center.
The enrolled patients were pretreated with Thymoglobulin and methylprednisolone induction followed by combination therapy with both sirolimus (Rapa) and tacrolimus (FK) for 6 months. At 6 months, those without rejection on protocol biopsy with good tolerance to both drugs were randomized either Rapa or FK monotherapy and followed up for 48 months.
Participant milestones
| Measure |
Sirolimus Group
Patients treated with sirolimus monotherapy from 6 months after combination therapy
|
Tacrolimus Group
Patients treated with tacrolimus monotherapy from 6 months after combination therapy
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
Sirolimus Group
Patients treated with sirolimus monotherapy from 6 months after combination therapy
|
Tacrolimus Group
Patients treated with tacrolimus monotherapy from 6 months after combination therapy
|
|---|---|---|
|
Overall Study
Drug intolerance
|
8
|
8
|
Baseline Characteristics
Combination Drug Therapy Followed by Single Drug Steroid Free Therapy to Prevent Organ Rejection in Kidney Transplantation
Baseline characteristics by cohort
| Measure |
Sirolimus Group
n=7 Participants
Patients treated with sirolimus monotherapy from 6 months after combination therapy
|
Tacrolimus Group
n=8 Participants
Patients treated with tacrolimus monotherapy from 6 months after combination therapy
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
44.4 years
STANDARD_DEVIATION 13.1 • n=99 Participants
|
45.0 years
STANDARD_DEVIATION 15.2 • n=107 Participants
|
44.7 years
STANDARD_DEVIATION 13.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Sirolimus Group
n=7 Participants
Patients treated with sirolimus monotherapy from 6 months after combination therapy
|
Tacrolimus Group
n=8 Participants
Patients treated with tacrolimus monotherapy from 6 months after combination therapy
|
|---|---|---|
|
The Rate of Allograft Rejection
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Sirolimus Group
n=7 Participants
Patients treated with sirolimus monotherapy from 6 months after combination therapy
|
Tacrolimus Group
n=8 Participants
Patients treated with tacrolimus monotherapy from 6 months after combination therapy
|
|---|---|---|
|
The Rate of Significant Drug-associated Complications.
|
0 participants
|
0 participants
|
Adverse Events
Sirolimus Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tacrolimus Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place