NCT00204191

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 19, 2007

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

October 18, 2007

Conditions

Kidney Transplantation

Keywords

kidney transplantationImmunosuppressionCyclosporineTacrolimus

Outcome Measures

Primary Outcomes (2)

  • graft survival

    at one year

  • patient survival

    at one year

Secondary Outcomes (3)

  • renal function measured by serum creatinine (SCr)

    at one year

  • lipid profile

    throughout the study

  • total cost of the treatment

Interventions

tacrolimusDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9

Bydgoszcz, 85-084, Poland

RECRUITING

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Zbigniew Wlodarczyk, MD, PhD

    Klinika Transplantologii, Collegium Medicum UMK Torun

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zbigniew Wlodarczyk, MD, PhD

CONTACT

+48 52 585 4044kiktranspl@cm.umk.pl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

May 1, 2003

Study Completion

December 1, 2007

Last Updated

October 19, 2007

Record last verified: 2005-09

Locations

PL(1)