Phase 4
N=162
A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients
Heart Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00862979 ↗Enrolled (actual)
162
Serious AEs
42.6%
Results posted
Jun 2018
Primary outcome: Primary: Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18 — 54.2; 66.9 mL/min — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Everolimus (EVR) (Drug); cyclosporine A (CyA) (Drug); tacrolimus (TAC) (Drug); Enteric coated mycophenolate sodium (EC-MPS) (Drug); mycophenolate mofetil (MMF) (Drug); Corticosteroids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18 |
54.2; 66.9 | <.0001 sig |
| SECONDARY Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18 |
1; 4; 3; 15 | 0.203 |
| SECONDARY Occurrence of Major Cardiac Events (MACE) From Month 6 to 18 |
1; 0; 0; 1 | — |
| SECONDARY Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 12 and 18 |
54.2; 69.8; 54.2; 66.9 | <.0001 sig |
| SECONDARY Serum Creatinine at Month 6, 8, 9, 10 12 and 18 |
1.53; 1.49; 1.44; 1.27; 1.58; 1.24 | — |
| SECONDARY Reciprocal Creatinine Slope Between Month 6 and Month 18 |
0.045; 0.403 | 0.008 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00862979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.