Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

NCT00452361 | Terminated Phase 4 Results

• 1 other identifier: 0468H-101864
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic allograft nephropathy (CAN).

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Change in Glomerular Filtration Rate (GFR) Change From Baseline

  GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR \<15 is consistent with kidney failure.

  104 weeks

Secondary Outcomes (18)

• Change in Glomerular Filtration Rate (GFR)

  Baseline and Week 24

• Change in Glomerular Filtration Rate (GFR)

  Baseline and Week 52

• Change in Glomerular Filtration Rate (GFR)

  Baseline and Week 104

• Patient and Graft Survival

  Week 24

• Patient and Graft Survival

  Week 52

Study Arms (2)

1

EXPERIMENTAL

Sirolimus therapy

Drug: Sirolimus+MMF or MPS or AZA+Steroid

2

ACTIVE COMPARATOR

Calcineurin Inhibitor therapy (either cyclosporine or tacrolimus)

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

Interventions

Sirolimus+MMF or MPS or AZA+Steroid DRUG

Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.

1

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

The maintenance dose of: 1. MMF will not exceed 1500 mg/day or PMS will not exceed 1080 mg/day 2. AZA will not exceed 75 mg/day Thereafter, at the discretion of the investigator, MMF/MPS or AZA may be: 1. continued for the entire 104-week period of randomized therapy 2. subsequently discontinued 3. restarted after discontinuation

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

Select Cities, Taiwan

Location

MeSH Terms

Interventions

Calcineurin Inhibitors

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

Study terminated early due to difficulties in enrolling qualified patients. No patients completed 104 weeks (primary outcome); a few completed 60 weeks. Insufficient data were available for efficacy analyses.

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2007
• First Posted: March 27, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 3, 2012
• Results First Posted: September 3, 2012

Record last verified: 2012-07

Locations

TW (1)