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Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients

A Partially Blinded, Prospective, Randomized Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral Sotrastaurin Plus Standard or Reduced Exposure Tacrolimus vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients

NCT01064791•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Recipients of a first or second kidney transplant from a deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor.
•Recipients of a kidney with a cold ischemia time \< 30 hours.
•Recipients of a kidney from a donor 10 - 65 years old.

Exclusion Criteria

•Multi-organ transplant recipients.
•Recipients of an organ from an non-heart beating donor.
•Patients receiving a second kidney allograft if the first allograft was
•Functional for less than three years
•Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) at screening and cannot discontinue this treatment.

Locations (44)

Novartis Investigative Site

Birmingham, Alabama, United States

Novartis Investigative Site

Aurora, Colorado, United States

Novartis Investigative Site

Ann Arbor, Michigan, United States

Novartis Investigative Site

Detroit, Michigan, United States

Novartis Investigative Site

Cincinnati, Ohio, United States

Novartis Investigative Site

Cincinnati, Ohio, United States

Novartis Investigative Site

Madison, Wisconsin, United States

Novartis Investigative Site

Corrientes, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Córdoba, Argentina

Key Dates

Start Date

December 1, 2009

Primary Completion Date

August 1, 2012

Completion Date

August 1, 2012

Last Updated

December 22, 2020

Enrollment

298

ACTUAL participants

Conditions

Renal Transplantation

Interventions

sotrastaurin (Dose 1) + tacrolimus + standard of care medications

DRUG

sotrastaurin (Dose 2) + tacrolimus + standard of care medications

DRUG

sotrastaurin (Dose 3) + tacrolimus + standard of care medications

DRUG

mycophenolic acid + tacrolimus + standard of care medications

DRUG

The Effect of Emotion-Focused Intervention on Emotion Regulation and Well-Being of Individuals With Transplantation

NCT07294183

Renal Transplantation

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RECRUITINGPHASE2

Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

NCT05086003

Renal Transplantation

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ACTIVE_NOT_RECRUITINGPHASE2

Mesenchymal Stromal Cells in Living Donor Kidney Transplantation

NCT03478215

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients

Inclusion Criteria

Exclusion Criteria

The Effect of Emotion-Focused Intervention on Emotion Regulation and Well-Being of Individuals With Transplantation

Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Mesenchymal Stromal Cells in Living Donor Kidney Transplantation

Tolerance by Engaging Antigen During Cellular Homeostasis

Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients

Urinary Biomarkers in Paediatric Kidney Transplantation (pKTx)