Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00452361
• Date of registration: 23/03/2007
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient
• Scientific title: A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipient
• Date of first enrolment: April 2007
• Target sample size: 31
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00452361
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Taiwan

Contacts

• Name: Medical Monitor
• Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects must be at least 18 years of age.

- Subjects who are 6 to 60 months after renal transplantation.

- Subjects who have a stable graft function.

Exclusion Criteria:

- Subjects with active major infection, including HIV, decreased platelets, elevated
lipids, or multiple organ transplants.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney Transplantation

Intervention(s)

Drug: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid

Drug: Sirolimus+MMF or MPS or AZA+Steroid

Primary Outcome(s)

Change in Glomerular Filtration Rate (GFR) Change From Baseline [Time Frame: 104 weeks]

Secondary Outcome(s)

Change From Baseline in Diastolic Blood Pressure at Week 104 [Time Frame: Baseline and Week 104]

Change From Baseline in Diastolic Blood Pressure at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in Diastolic Blood Pressure at Week 52 [Time Frame: Baseline and Week 52]

Change From Baseline in Systolic Blood Pressure at Week 104 [Time Frame: Baseline and Week 104]

Change From Baseline in Systolic Blood Pressure at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in Systolic Blood Pressure at Week 52 [Time Frame: Baseline and Week 52]

Change From Baseline in the Severity and Progression of Biopsy-Confirmed Chronic Allograft Nephropathy (CAN) at Week 104 [Time Frame: Baseline and Week 104]

Change in Glomerular Filtration Rate (GFR) [Time Frame: Baseline and Week 104]

Change in Glomerular Filtration Rate (GFR) [Time Frame: Baseline and Week 24]

Change in Glomerular Filtration Rate (GFR) [Time Frame: Baseline and Week 52]

Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 104 [Time Frame: Week 104]

Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 24 [Time Frame: Week 24]

Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 52 [Time Frame: Week 52]

Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 104 [Time Frame: Week 104]

Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 52 [Time Frame: Weeks 52]

Patient and Graft Survival [Time Frame: Week 104]

Patient and Graft Survival [Time Frame: Week 24]

Patient and Graft Survival [Time Frame: Week 52]

Secondary ID(s)

0468H-101864

Source(s) of Monetary Support

Please refer to primary and secondary sponsors