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A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients

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: NCT00195429
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : June 2, 2009
Last Update Posted : April 28, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.

Condition or disease Intervention/treatment Phase
Kidney Failure Graft vs Host Disease Drug: Tacrolimus Drug: Sirolimus Drug: prednisone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients
Study Start Date : August 2005
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: Sirolimus + Tacrolimus Drug: Tacrolimus
Drug: Sirolimus
Active Comparator: Sirolimus + Prednisone Drug: Sirolimus
Drug: prednisone



Primary Outcome Measures :
  1. Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up. [ Time Frame: 12 months ]
    Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).


Secondary Outcome Measures :
  1. Creatinine Clearance Rate [ Time Frame: 12 months ]
    Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.



Information from the National Library of Medicine

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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:

  • 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.


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): NCT00195429


Locations
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Brazil
Sao Paulo, Brazil
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
Principal Investigator: Trial Manager For Brazil, xavierl@wyeth.com

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ClinicalTrials.gov Identifier: NCT00195429    
Other Study ID Numbers: 0468E-101535
First Posted: September 19, 2005    Key Record Dates
Results First Posted: June 2, 2009
Last Update Posted: April 28, 2010
Last Verified: April 2010
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
Prednisone
Everolimus
Tacrolimus
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents