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A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients (MANDELA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00862979
First Posted: March 17, 2009
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.

Condition Intervention Phase
Heart Transplantation Drug: Sandimmun Optoral / Tac + RAD001 Drug: MPA + RAD001 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 15-month, Multi-center, Randomized, Open-label, Parallel Group Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Regimen (Everolimus and Mycophenolic Acid) Versus a Standard Regimen (Cyclosporine A and Everolimus) in de Novo Heart Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Renal function assessed as glomerular filtration rate (GFR) - MDRD formula [ Time Frame: 18 months after heart transplantation ]

Secondary Outcome Measures:
  • Occurrence of treatment failures [ Time Frame: up to or at Month 18 ]
  • incidence of major cardiac events and each of its components [ Time Frame: Month 18 ]
  • renal function by GFR - Cockcroft-Gault method [ Time Frame: Month 12 and 18 ]
  • renal function and evolution of renal function (creatinine slope) [ Time Frame: between Month 6 and Month 18 ]
  • safety and tolerability [ Time Frame: Month 6, 9 and 18 ]

Enrollment: 185
Actual Study Start Date: February 24, 2009
Study Completion Date: March 6, 2017
Primary Completion Date: March 6, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Certican CNI
MMF OR Myfortic, Certican®, Sandimmun® optoral reduced
Drug: Sandimmun Optoral / Tac + RAD001
RAD001 / CNI group
Experimental: Certican
MMF or Myfortic+ Everolimus + corticosteroids
Drug: MPA + RAD001
RAD001 / MPA group

Detailed Description:
This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Heart transplantation, 3 months prior to enrollment
  • Patients have to receive an immunosuppressive regimen with Sandimmun® Optoral, Certican® and corticosteroids
  • Sufficient graft function
  • Sufficient renal function
  • Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility

Exclusion criteria:

  • Multi-organ recipients, re-transplantation, or previous transplant with any other organ.
  • Patients who are recipients of A-B-O incompatible transplants
  • Cold ischemia time >6 hours
  • Historical or current peak PRA of > 25% at time of transplantation
  • Already existing antibodies against the HLA-type of the receiving transplant Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862979


Locations
Germany
Novartis Investigative Site
Bad Oeynhausen, Germany, 32545
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Hamburg, Germany, 20246
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Leipzig, Germany, 04289
Novartis Investigative Site
Muenster, Germany, 48149
Novartis Investigative Site
München, Germany, 81377
Novartis Investigative Site
Regensburg, Germany, 93053
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00862979     History of Changes
Other Study ID Numbers: CRAD001ADE14
2007-002671-14
First Submitted: March 16, 2009
First Posted: March 17, 2009
Last Update Posted: September 7, 2017
Last Verified: September 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Heart Transplantation
Cardiac Transplantation
CNI-sparing
renal function
CNI
Cyclosporine A
Everolimus
enteric coated mycophenolic acid

Additional relevant MeSH terms:
Everolimus
Sirolimus
Mycophenolic Acid
Cyclosporins
Cyclosporine
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents