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An open, multicentre, randomised, parallel group study to compare the safety and efficacy of a tacrolimus/azathioprine/steroid triple regimen with and without the induction of the monoclonal antibody basiliximab in children after 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-506-02-35

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

N/A - 18 Years

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

Mar 2001 - Mar 2004

Masking

None (Open Label)

Enrollment number

197

An open, multicentre, randomised, parallel group study to compare the safety and efficacy of a tacrolimus/azathioprine/steroid triple regimen with and without the induction of the monoclonal antibody basiliximab in children after 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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