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A multicentre, randomised, open clinical study to compare the efficacy and safety of a combination of tacrolimus with sirolimus versus a tacrolimus / mycophenolate mofetil based regimen in kidney transplantation

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.

N/A

Astellas Study ID

The unique identification code given by the study sponsor.

FG-506-02-39

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Kidney Transplants

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 Years - N/A

Sex

Female & Male

Product

tacrolimus

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

May 2002 - Sep 2003

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

995

A multicentre, randomised, open clinical study to compare the efficacy and safety of a combination of tacrolimus with sirolimus versus a tacrolimus / mycophenolate mofetil based regimen in kidney transplantation

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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