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)
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| ClinicalTrials.gov Identifier: NCT00862979 |
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Recruitment Status
:
Completed
First Posted
: March 17, 2009
Last Update Posted
: September 7, 2017
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Transplantation | Drug: Sandimmun Optoral / Tac + RAD001 Drug: MPA + RAD001 | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 185 participants |
| 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 |
| Actual Study Start Date : | February 24, 2009 |
| Actual Primary Completion Date : | March 6, 2017 |
| Actual Study Completion Date : | March 6, 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Transplantation
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Certican CNI
MMF OR Myfortic, Certican®, Sandimmun® optoral reduced
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Drug: Sandimmun Optoral / Tac + RAD001
RAD001 / CNI group
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Experimental: Certican
MMF or Myfortic+ Everolimus + corticosteroids
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Drug: MPA + RAD001
RAD001 / MPA group
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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 ]
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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
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 |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00862979 History of Changes |
| Other Study ID Numbers: |
CRAD001ADE14 2007-002671-14 |
| First Posted: | March 17, 2009 Key Record Dates |
| Last Update Posted: | September 7, 2017 |
| Last Verified: | September 2017 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Heart Transplantation Cardiac Transplantation CNI-sparing renal function |
CNI Cyclosporine A Everolimus enteric coated mycophenolic acid |
Additional relevant MeSH terms:
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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 |