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Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients. | Clinical Trials | Clareo Health

TERMINATEDPHASE4

Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.

Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a CNI-free Regimen With Enteric-coated Mycophenolate Sodium and Everolimus in Comparison to Standard Therapy With Enteric-coated Mycophenolate Sodium and Ciclosporin Microemulsion in Stable Renal Transplant Patients

NCT00332839•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant recipients to prevent graft rejection, may cause renal impairment. The aim of this study is to assess whether a CNI-free regimen with enteric-coated mycophenolate sodium and everolimus is as safe and well tolerated as a standard regimen consisting of enteric-coated mycophenolate sodium and cyclosporine microemulsion without a compromise in therapeutic efficacy while resulting in an improved renal function.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or females, aged \> 18 years, Maintenance renal transplant recipients at least 6 months post-transplantation, Patients with a serum creatinine \< 2,5 mg/dL stable for at least three month (according to the investigator), Females capable of becoming pregnant had to have a negative serum pregnancy test within seven days prior to or at baseline, and were required to practice an approved method of birth control for the duration of the study and for a period of six weeks following discontinuation of study medication, even where there had been a history of infertility, Patients receiving Myfortic® (Myfortic dose . 720 mg/d) and Sandimmun® Optoral with or without corticosteroids as part of their immunosuppressive regimen for at least 1 month before baseline;

Exclusion Criteria

•More than one previous renal transplantation, Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney, Patient with proteinuria \> 1000 mg/day at baseline, Hypersensitivity to Certican®, Sandimmun® Optoral, Prograf®, mycophenolic acid, or other components of the formulation, Patients who had received an investigational drug within four weeks prior to baseline, Severe rejection (≥ Banff II acute rejection), recurrent acute rejection, or steroid resistant rejection within six months of enrollment, Thrombocytopenia (platelets \< 100,000/mm³), with an absolute neutrophil count of \< 1,500/mm³ or leukopenia (leukocytes \< 4,000/mm³), or hemoglobin \< 8 g/dL, Abnormal physical or laboratory findings of clinical significance within two weeks of study inclusion which at the investigator's discretion would interfere with the objectives of the study, Symptoms of significant somatic or mental illness. Inability to cooperate or communicate with the investigator, or patients who were unlikely to comply with the study requirements, or who were unable to give informed consent, History of malignancy during the last five years, except squamous or basal cell carcinoma of the skin, Patients who were HIV positive, or hepatitis C, or hepatitis B surface antigen positiveEvidence of severe liver disease (including abnormal liver enzyme profile, i.e. aspartate transaminase (AST), alanine aminotransferase (ALT) or total bilirubin \> 3 times upper limit of normal (ULN), Females of childbearing potential who were planning to become pregnant, who were pregnant or lactating and/or who were unwilling to use effective means of contraception, Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study, Evidence of drug or alcohol abuse

Locations (11)

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Cologne, Germany

Novartis Investigative Site

Erlangen, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Hanover, Germany

Novartis Investigative Site

Heidelberg, Germany

Novartis Investigative Site

Heilbronn, Germany

Novartis Investigative Site

Kaiserslautern, Germany

Novartis Investigative Site

Kiel, Germany

Key Dates

Start Date

November 1, 2005

Primary Completion Date

March 1, 2013

Completion Date

March 1, 2013

Last Updated

August 28, 2014

Enrollment

ACTUAL participants

Conditions

Renal Transplantation

Interventions

Everolimus

DRUG

Cyclosporin A (CsA)

DRUG

Tacrolimus

DRUG

Enteric Coated - Mycophenolate Sodium (EC-MPS)

DRUG

Corticosteroids

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: August 28, 2014Data 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.

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Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.

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)