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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 December 2023 |
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Main ID: |
NCT00195429 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
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Scientific title:
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A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients |
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Date of first enrolment:
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August 2005 |
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Target sample size:
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47 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT00195429 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Brazil, xavierl@wyeth.com |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- End-stage renal disease, with patients scheduled to receive a kidney transplant.
- Women who are of childbearing potential who are not pregnant and agree to use a
medically acceptable method of contraception throughout the treatment period and for 3
months following discontinuation of study drugs. Any woman becoming pregnant during
the treatment period must discontinue the use of study drugs;
- Signed informed consent.
Exclusion Criteria:
- Evidence of active systemic or localized major infection at the time of initial study
drug administration;
- Multiple organ transplants;
- Any pathology or medical condition that can interfere with this protocol study
proposal.
Other exclusion applies.
Age minimum:
13 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Graft vs Host Disease
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Kidney Failure
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Intervention(s)
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Drug: prednisone
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Drug: Sirolimus
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Drug: Tacrolimus
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Primary Outcome(s)
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Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
[Time Frame: 12 months]
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Secondary Outcome(s)
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Creatinine Clearance Rate
[Time Frame: 12 months]
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Secondary ID(s)
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0468E-101535
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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