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A study to evaluate the efficacy and safety of tacrolimus with steroid in Korean lupus nephritis patients

Terminated/Withdrawn
The study has stopped early and will not start again. Participants were not enrolled (for withdrawn studies), however if participants were enrolled, they are no longer being examined or treated.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01316133

Astellas Study ID

The unique identification code given by the study sponsor.

PRGLN-10-01-KOR

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

Follow Trial

Condition

Lupus

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

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

Apr 2011 - Apr 2016

Masking

None (Open Label)

Enrollment number

37

A multicenter, non-comparative, open-labeled, prospective study to evaluate the efficacy and safety of tacrolimus (Prograf®) with steroid in Korean lupus nephritis patients who are non-responders to steroid monotherapy

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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