Study Evaluating Sirolimus in Kidney Transplant Recipients in India

Kidney Failure Clinical Trial

Official title:

A Post Marketing Surveillance Looking at Safety of Rapamune (Sirolimus) in Indian Population Undergoing de Novo Renal Transplantation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195481
• Other study ID #: 0468H-101543
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: December 21, 2007
• Start date: April 2004
• Est. completion date: December 2005

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• Patients in End Stage Renal Disease who are above 13 years of age and weigh more than 40 kilograms.

• Patients scheduled to receive a kidney from a cadaveric donor, from a living unrelated donor or from a living related donor.

Exclusion Criteria:

• Evidence of major infections at the time of sirolimus administration

• Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the treatment phase.

• Females who are pregnant, breast feeding or in reproductive age group and not using a medically acceptable form of contraception

Study Design

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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• Rapamune

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety evaluation