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=5 Participants	45.0 years STANDARD_DEVIATION 15.2 • n=7 Participants	44.7 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Outcome 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 years

Outcome 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

Dr. Monique Cho

NIDDK, National Institutes of Health

Phone: 3014355058

Email: moniquec@intra.niddk.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place