Trial Outcomes & Findings for Sirolimus and Thymoglobulin to Prevent Kidney Transplant Rejection (NCT NCT00006178)

NCT ID: NCT00006178

Last Updated: 2019-09-17

Results Overview

measures at 6 months after intervention

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 6 months after intervention
• Results posted on: 2019-09-17

Participant Flow

Participant milestones

Measure	Sirolimus and Thymoglobulin Thymoglobulin (Sangstat) will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst)
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sirolimus and Thymoglobulin to Prevent Kidney Transplant Rejection

Baseline characteristics by cohort

Measure	Sirolimus and Thymoglobulin n=12 Participants Thymoglobulin (Sangstat) will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45.0 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after intervention

Population: Analysis includes all participants in the study. Analysis was per protocol.

measures at 6 months after intervention

Outcome measures

Measure	Sirolimus and Thymoglobulin n=12 Participants Thymoglobulin (Sangstat) will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst)
Serum Creatinine Concentration	112 umol/L Standard Deviation 34

PRIMARY outcome

Timeframe: 12 months after intervention

measures at 12 months after intervention

Outcome measures

Measure	Sirolimus and Thymoglobulin n=12 Participants Thymoglobulin (Sangstat) will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst)
Serum Creatinine Concentration	107 umol/L Standard Deviation 25

SECONDARY outcome

Timeframe: 6 month after intervention

measure 6 months after intervention

Outcome measures

Measure	Sirolimus and Thymoglobulin n=12 Participants Thymoglobulin (Sangstat) will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst)
Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney)	69.1 mL/min Standard Deviation 17.4

SECONDARY outcome

Timeframe: 12 months after intervention

measure at 12 months after intervention

Outcome measures

Measure	Sirolimus and Thymoglobulin n=12 Participants Thymoglobulin (Sangstat) will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst)
Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney)	74.2 mL/min Standard Deviation 21.3

Adverse Events

Sirolimus and Thymoglobulin

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sirolimus and Thymoglobulin n=12 participants at risk Thymoglobulin (Sangstat) will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst)
Renal and urinary disorders Acute cellular rejection	25.0% 3/12 • Number of events 3

Other adverse events

Measure	Sirolimus and Thymoglobulin n=12 participants at risk Thymoglobulin (Sangstat) will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst)
General disorders varicella zoster reactivation	8.3% 1/12 • Number of events 1
Renal and urinary disorders bacterial urnary tract infection	16.7% 2/12 • Number of events 2
Metabolism and nutrition disorders diabetic foot cellulitis	8.3% 1/12 • Number of events 1
General disorders hernia	16.7% 2/12 • Number of events 2
Immune system disorders lymphocoele	8.3% 1/12 • Number of events 1
General disorders postpolio motor neuropathy	8.3% 1/12 • Number of events 1
General disorders Sirolimus-side-effect (diarrhoea)	25.0% 3/12 • Number of events 3
General disorders Sirolimus-side-effect (mouth ulcers)	66.7% 8/12 • Number of events 8
General disorders Sirolimus-side-effect (arthralgias)	16.7% 2/12 • Number of events 2
General disorders Sirolimus-side-effect (hyperlipidaemia)	83.3% 10/12 • Number of events 10

Additional Information

Dr. Allan D. Kirk

National Institutes of Health

Email: allank@intra.niddk.nih.gov

Results disclosure agreements

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