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Study Evaluating Sirolimus in Kidney Transplant Recipients in India

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00195481
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
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 : April 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Safety evaluation


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195481


Locations
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India
Bangalore, Karnataka, India, 566 006
Bangalore, Karnataka, India, 566 018
Saket, South Delhi, India
Chennai, Tamil Nadu, India, 600 004
New Delhi, India
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00195481    
Other Study ID Numbers: 0468H-101543
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Kidney
Transplant
Additional relevant MeSH terms:
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Renal Insufficiency
Graft vs Host Disease
Kidney Diseases
Urologic Diseases
Immune System Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs