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A study to assess the efficacy and safety of Advagraf® switching from Cyclosporine between the group that was treated with a 50% reduced corticosteroid and the group with maintained corticosteroid for stable kidney transplant recipients

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.
NCT02034747

Astellas Study ID

The unique identification code given by the study sponsor.

ADV-KT-13-01

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 happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

20 years - N/A

Sex

Female & Male

Product

tacrolimus extended-release

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

Nov 2013 - Nov 2015

Masking

None (Open Label)

Enrollment number

150

A multicenter, randomized, comparison, open-label, phase IV study to assess the efficacy and safety of Advagraf® switching from Cyclosporine between the group that was treated with a 50% reduced corticosteroid and the group with maintained corticosteroid for stable kidney transplant recipients

Study summary

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