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Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Uniwersytet Mikolaja Kopernika w Toruniu.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
Uniwersytet Mikolaja Kopernika w Toruniu
ClinicalTrials.gov Identifier:
NCT00204191
First received: September 12, 2005
Last updated: October 18, 2007
Last verified: September 2005
History of Changes
  Purpose

The purpose of this study is to evaluate and compare, in the single center setting, the safety, efficacy and cost-effectiveness of the two standard immunosuppressive regimens based on tacrolimus and cyclosporine.


Condition Intervention Phase
Kidney Transplantation
 Drug: tacrolimus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open, Prospective, Randomized Study to Compare the Efficacy and Safety of Immunosuppression Regimens Based on Cyclosporine (Neoral®) and Tacrolimus (Prograf®) in Renal Transplant Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uniwersytet Mikolaja Kopernika w Toruniu:

Primary Outcome Measures:
  • graft survival [ Time Frame: at one year ]
  • patient survival [ Time Frame: at one year ]

Secondary Outcome Measures:
  • renal function measured by serum creatinine (SCr) [ Time Frame: at one year ]
  • lipid profile [ Time Frame: throughout the study ]
  • total cost of the treatment

Estimated Enrollment: 300
Study Start Date: May 2003
Estimated Study Completion Date: December 2007
Detailed Description:

Despite several multicenter studies, there is no hard evidence on the superiority of a cyclosporine or tacrolimus based immunosuppressive regimen following kidney transplantation, in a single-center setting. Existing studies concentrated on benefits in safety and efficacy, but seldomly evaluated the cost-effectiveness of one treatment.

The study has been designed in a fashion as close to the daily clinical practice as possible. Patients are randomized in pairs, receiving kidneys from the same donor, thus avoiding donor-related bias. Those having specific indications or contraindications for one of the study medications were not entered into the study. All other study-related decisions are made only on a clinical basis and according to the standard practice of the center. Patients are followed on the intention-to-treat rule. Cost-effectiveness will be calculated on 12-month treatment for each patient entered into the study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First or second cadaveric kidney transplantation
  • Age over 18 years old
  • Specific indications or contraindications for cyclosporine or tacrolimus are absent
  • Informed consent

Exclusion Criteria:

  • Specific indications for use of cyclosporine or tacrolimus
  • Specific contraindications for use of cyclosporine or tacrolimus
  • Participation in another interventional clinical trial
  • Pregnancy or lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204191

Contacts
Contact: Zbigniew Wlodarczyk, MD, PhD +48 52 585 4044 kiktranspl@cm.umk.pl

Locations
Poland
Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9 Recruiting
Bydgoszcz, Poland, 85-084
Principal Investigator: Zbigniew Wlodarczyk, MD            
Sub-Investigator: Andrzej Adamowicz, MD            
Sponsors and Collaborators
Uniwersytet Mikolaja Kopernika w Toruniu
Astellas Pharma Inc
Investigators
Principal Investigator: Zbigniew Wlodarczyk, MD, PhD Klinika Transplantologii, Collegium Medicum UMK Torun
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00204191     History of Changes
Other Study ID Numbers: 1/25/03, IDS PL-02-RG-122
Study First Received: September 12, 2005
Last Updated: October 18, 2007
Health Authority: Poland: Ministry of Health

Keywords provided by Uniwersytet Mikolaja Kopernika w Toruniu:
kidney transplantation
Immunosuppression
Cyclosporine
Tacrolimus

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 18, 2013