Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants

Kidney Transplant Clinical Trial

Official title:

A Nonrandomized, Open-label, Multicenter, Sequential Phase Study to Evaluate the Safety and Efficacy of Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese De Novo Renal Allograft Recipients Receiving Rapamune

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257387
• Other study ID #: 0468H1-101308
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 4, 2005
• Last updated: February 1, 2011
• Start date: June 2004
• Est. completion date: August 2006

Study information

• Verified date: June 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Evaluate the incidence of acute rejection at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Phase I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Phase II) in Chinese de novo renal allograft recipients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with end-stage renal disease scheduled to receive a primary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor.

• Subjects must be at least 18 years of age.

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• Cyclosporine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence and severity of acute rejection in renal allograft recipients at 6 months post-transplantation.
Secondary	To evaluate the treatment groups with respect to incidence of adverse events, renal function, subject and graft survival at 6 and 12 months, and the incidence and severity of acute rejection at 12 months post-transplantation.