Study Details

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To compare the effects of immediate-release tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) formation and the development of Immune Activation (IA) in de novo 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.
NCT02723591

Astellas Study ID

The unique identification code given by the study sponsor.

IDTX-MA-3004

EudraCT ID

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

2018-003867-79

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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

16 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

Sep 2016 - Jun 2019

Masking

None (Open Label)

Enrollment number

599

Astagraf XL® to Understand the Impact of Immunosuppression on De Novo DSA Development and Chronic Immune Activation 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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Would you like more information about clinical trial sites that are recruiting participants for To compare the effects of immediate-release tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) formation and the development of Immune Activation (IA) in de novo kidney transplant recipients? Contact us by filling our your information to the right and we’ll respond to you.

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Locations

Site US10023

Madison, United States, 53792

Site US10037

New York, United States, 10032

Site US10002

Charleston, United States, 29425

Site US10020

Chicago, United States, 60605

Site US10021

Syracuse, United States, 13210

Site US10001

Baltimore, United States, 21201

Site US10005

Sacramento, United States, 95817

Site US10014

Washington, United States, 20007

Site US10029

Minneapolis, United States, 55455

Site US10027

Rochester, United States, 55905

Site US10003

New Haven, United States, 06510

Site US10028

New York, United States, 10467

Site US10031

Los Angeles, United States, 90033

Site US10016

San Francisco, United States, 94115

Site US10013

Ann Arbor, United States, 48109

Site US10022

New York City, United States, 10065

Site US10036

Houston, United States, 77030

Site US10019

Livingston, United States, 07039

Site US10018

Salt Lake City, United States, 84112

Site US10012

Charlottesville, United States, 22903

Site US10008

Falls Church, United States, 22042

Site US10010

Chicago, United States, 60611

Site US10007

Boston, United States, 02114

Site US10026

Portland, United States, 97210

Site US10032

Detroit, United States, 48202

Site US10004

Buffalo, United States, 14215

Site US10024

Aurora, United States, 80045

Site US10006

Birmingham, United States, 35294

Site US10035

Los Angeles, United States, 90048

Site US10025

Scottsdale, United States, 85259

Site US10030

Jacksonville, United States, 32224

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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