Study Details

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A study to compare the efficacy and safety of FK506MR vs Prograf® in patients undergoing 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.
NCT00481819

Astellas Study ID

The unique identification code given by the study sponsor.

MR4KTxCN01

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

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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 - 70 Years

Sex

Female & Male

Product

N/A

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

Jul 2007 - Mar 2009

Masking

None (Open Label)

Enrollment number

240

A multicenter, randomized, open label, parallel study to evaluate and compare the efficacy and safety of FK506MR vs Prograf® in combination with MMF and steroids in patients undergoing kidney transplantation and a pharmacokinetics study.

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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Locations

3 Sites

Beijing, China

2 Sites

Shanghai, China

Shenyang, China

Hangzhou, China

2 Sites

Guangzhou, China

Wuhan, China

Fuzhou, China

Chongqing, China

Changsha, China

The purpose of this website is to offer education and information to patients and their families and friends, the public, and healthcare professionals about the clinical trial process. In addition, the website will provide specific information about Astellas clinical trials. Please read the complete Astellas Transparency Policy to learn about the clinical trial information available on this website

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