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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00862979
First received: March 16, 2009
Last updated: June 18, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Primary Outcome Measures:
  • Renal function assessed as glomerular filtration rate (GFR) - MDRD formula [ Time Frame: 18 months after heart transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of treatment failures [ Time Frame: up to or at Month 18 ] [ Designated as safety issue: Yes ]
  • incidence of major cardiac events and each of its components [ Time Frame: Month 18 ] [ Designated as safety issue: Yes ]
  • renal function by GFR - Cockcroft-Gault method [ Time Frame: Month 12 and 18 ] [ Designated as safety issue: No ]
  • renal function and evolution of renal function (creatinine slope) [ Time Frame: between Month 6 and Month 18 ] [ Designated as safety issue: No ]
  • safety and tolerability [ Time Frame: Month 6, 9 and 18 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: February 2009
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862979

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Germany
Novartis Investigative Site Recruiting
Bad Oeynhausen, Germany, 32545
Novartis Investigative Site Recruiting
Berlin, Germany, 13353
Novartis Investigative Site Withdrawn
Dresden, Germany, 01307
Novartis Investigative Site Recruiting
Hamburg, Germany, 20246
Novartis Investigative Site Recruiting
Hannover, Germany, 30625
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Leipzig, Germany, 04289
Novartis Investigative Site Recruiting
Muenster, Germany, 48149
Novartis Investigative Site Recruiting
München, Germany, 81377
Novartis Investigative Site Recruiting
Regensburg, Germany, 93053
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00862979     History of Changes
Other Study ID Numbers: CRAD001ADE14, 2007-002671-14
Study First Received: March 16, 2009
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on July 23, 2014