Study Evaluating Sirolimus in Kidney Transplant Recipients in India

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00195481

Enrollment

100

Registered

2005-09-19

Start date

2004-04-30

Completion date

2005-12-31

Last updated

2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft vs Host Disease, Kidney Failure

Keywords

Kidney, Transplant

Brief summary

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

Interventions

DRUGRapamune

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety evaluation	—

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026