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OpenTrials
Completed

NCT Number: NCT00195481

Study Evaluating Sirolimus in Kidney Transplant Recipients in India

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

Completed

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Key information

Conditions

Kidney Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft vs Host Disease Immune System Diseases Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bangalore, Karnataka, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapamune

Drug

Primary outcomes

  1. Safety evaluation

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
Dec 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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