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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00204191
Other study ID # 1/25/03
Secondary ID IDS PL-02-RG-122
Status Recruiting
Phase Phase 4
First received September 12, 2005
Last updated October 18, 2007
Start date May 2003
Est. completion date December 2007

Study information

Verified date September 2005
Source Uniwersytet Mikolaja Kopernika w Toruniu
Contact Zbigniew Wlodarczyk, MD, PhD
Phone +48 52 585 4044
Email kiktranspl@cm.umk.pl
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
tacrolimus


Locations

Country Name City State
Poland Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9 Bydgoszcz

Sponsors (2)

Lead Sponsor Collaborator
Uniwersytet Mikolaja Kopernika w Toruniu Astellas Pharma Inc

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary graft survival at one year
Primary patient survival at one year
Secondary renal function measured by serum creatinine (SCr) at one year
Secondary lipid profile throughout the study
Secondary total cost of the treatment
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