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

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. Identifier: NCT00204191
Recruitment Status : Unknown
Verified September 2005 by Uniwersytet Mikolaja Kopernika w Toruniu.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : October 19, 2007
Astellas Pharma Inc
Information provided by:
Uniwersytet Mikolaja Kopernika w Toruniu

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Transplantation Drug: tacrolimus Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : May 2003
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. graft survival [ Time Frame: at one year ]
  2. patient survival [ Time Frame: at one year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00204191

Contact: Zbigniew Wlodarczyk, MD, PhD +48 52 585 4044

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
Principal Investigator: Zbigniew Wlodarczyk, MD, PhD Klinika Transplantologii, Collegium Medicum UMK Torun Identifier: NCT00204191     History of Changes
Other Study ID Numbers: 1/25/03
IDS PL-02-RG-122
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 19, 2007
Last Verified: September 2005

Keywords provided by Uniwersytet Mikolaja Kopernika w Toruniu:
kidney transplantation

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents