Study Evaluating Sirolimus in Kidney Transplant Recipients in India

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00195481
• Collaborator: (none)
• Enrollment: 100
• Locations: 5
• Duration (Months): 20
• Patients Per Site: 20
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure; Graft vs Host Disease	Drug: Rapamune	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Post Marketing Surveillance Looking at Safety of Rapamune (Sirolimus) in Indian Population Undergoing de Novo Renal Transplantation.
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: Dec 1, 2005
• Actual Study Completion Date: Dec 1, 2005

Outcome Measures

Primary Outcome Measures

1. Safety evaluation []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Bangalore	Karnataka	India	566 006
2		Bangalore	Karnataka	India	566 018
3		Saket	South Delhi	India
4		Chennai	Tamil Nadu	India	600 004
5		New Delhi		India

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00195481
• Other Study ID Numbers: 0468H-101543
• First Posted: Sep 19, 2005
• Last Update Posted: Dec 28, 2007
• Last Verified: Dec 1, 2007

• Keywords provided by , ,: Kidney; Transplant
• Additional relevant MeSH terms: Renal Insufficiency; Graft vs Host Disease; Sirolimus

Study Results

No Results Posted as of Dec 28, 2007