Trial Outcomes & Findings for Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure (NCT NCT00223678)

NCT ID: NCT00223678

Last Updated: 2017-06-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2017-06-21

Participant Flow

Participant milestones

Measure	Rapamycin pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15	CYA/Prograf Patient will remain on calcineurin inhibitor,CYA/Prograf
Overall Study STARTED	13	7
Overall Study COMPLETED	13	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure

Baseline characteristics by cohort

Measure	Rapamycin n=13 Participants pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15	CYA/Prograf n=7 Participants Patient will remain on calcineurin inhibitor,CYA/Prograf	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=93 Participants	7 Participants n=4 Participants	20 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	1 Participants n=4 Participants	6 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Region of Enrollment United States	13 participants n=93 Participants	7 participants n=4 Participants	20 participants n=27 Participants

PRIMARY outcome

Timeframe: 3 years

Outcome measures

Measure	Rapamycin Group n=13 Participants pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin.Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15	CNI Group n=7 Participants Patient will remain on calcineurin inhibitor with a low target serum levels 50ng/ml to 125ng/mg 12 hour trough
Graft Survival	13 participants Interval 1.0 to 36.0	7 participants Interval 1.0 to 36.0

Adverse Events

Rapamycin Group

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

CNI Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rapamycin Group n=13 participants at risk	CNI Group n=7 participants at risk
Respiratory, thoracic and mediastinal disorders pneumonia	30.8% 4/13 • Number of events 4	14.3% 1/7 • Number of events 1
Renal and urinary disorders acute kidney failure	15.4% 2/13 • Number of events 2	14.3% 1/7 • Number of events 1
Vascular disorders dehydration	7.7% 1/13 • Number of events 1	0.00% 0/7
Musculoskeletal and connective tissue disorders hip replacement	7.7% 1/13 • Number of events 1	0.00% 0/7
Renal and urinary disorders acute rejection	7.7% 1/13 • Number of events 1	0.00% 0/7
Reproductive system and breast disorders total abdominal hysterectomy and salpingectomy	7.7% 1/13 • Number of events 1	0.00% 0/7
Blood and lymphatic system disorders anemia	7.7% 1/13 • Number of events 1	0.00% 0/7

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anthony Langone

Vanderbilt Medical Center

Phone: 615-936-1179

Email: anthony.langone@vanderbilt.edu

Results disclosure agreements

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

Restriction type: LTE60