Status:
COMPLETED
Study Evaluating Sirolimus in Kidney Transplant Recipients in India
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Kidney Failure
Graft vs Host Disease
Eligibility:
All Genders
13+ years
Phase:
PHASE4
Brief Summary
To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00195481
Start Date
April 1 2004
End Date
December 1 2005
Last Update
December 28 2007
Active Locations (5)
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1
Bangalore, Karnataka, India, 566 006
2
Bangalore, Karnataka, India, 566 018
3
Sāket, South Delhi, India
4
Chennai, Tamil Nadu, India, 600 004