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Study Evaluating Sirolimus in Kidney Transplant Recipients in India

NCT ID: NCT00195481

Last Updated: 2007-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-12-31

Brief Summary

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

Detailed Description

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Conditions

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Kidney Failure Graft vs Host Disease

Keywords

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Kidney Transplant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rapamune

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Bangalore, Karnataka, India

Site Status

Bangalore, Karnataka, India

Site Status

Sāket, South Delhi, India

Site Status

Chennai, Tamil Nadu, India

Site Status

New Delhi, , India

Site Status

Countries

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India

Other Identifiers

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0468H-101543

Identifier Type: -

Identifier Source: org_study_id