A One Year, Multicenter, Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Cyclosporine Microemulsion in Cardiac Transplant Recipients.

Novartis Pharmaceuticals0 sitesSeptember 2004

ConditionsCardiac Transplantation

DrugsEverolimus (RAD001)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Cardiac Transplantation
Sponsor: Novartis Pharmaceuticals
Primary Endpoint: Comparing calculated glomerular filtration rate (GFR) at Month 3 (Week 12) to Baseline and by comparing the daily cyclosporine dose at Month 3 (Week 12) to Baseline.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of the study is to determine the extent of cyclosporine microemulsion dose reduction required to maintain stable renal function in maintenance cardiac transplant recipients, after initiation of everolimus.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

July 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female cardiac transplant recipients, 18-70 years old, with established cardiac allograft vasculopathy or at risk to develop a cardiac allograft vasculopathy.
•Patients who are more than 12 months post-transplant and who are receiving a cyclosporine microemulsion-based immunosuppressive regimen with/without azathioprine /mycophenolate mofetil, with/without steroids.
•Patients need to have stable renal function with a calculated GFR exceeding 40 ml/min (Nankivell).
•Patients without a biopsy-proven acute rejection ≥ grade 2, within 12 months prior to study entry.
•Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 4 weeks following discontinuation of the study medication, even where there has been a history of infertility.
•Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion Criteria

•Patients who are recipients of multiple solid organ transplants.
•Patients with a calculated GFR of less than 40 ml/min.
•Patients with a biopsy-proven acute rejection episode ≥ 2 within 12 months prior to study entry.
•Patients who had received any investigational drug within 4 weeks prior to study entry.
•Patients currently being treated with sirolimus or having a history of prior therapy or having a hypersensitivity to drug similar to everolimus.
•Patient with a platelet count of \< 50,000/mm3 or with a white blood cell count of ≤ 2,500/mm3 or with a hemoglobin value \< 10 g/dL.
•Presence of severe hypercholesterolemia (≥ 9.1 mmol/L) or hypertriglyceridemia (≥ 8.55 mmol/L).
•Patient with NYHA class IV heart failure, or with left ventricular ejection fraction \<30%. Patients with life-threatening cardiac allograft vasculopathy and/or graft dysfunction (life expectancy 1 year).
•Patients with severe systemic infections.
•Patients who are known to have HBsAg or HCV positive hepatitis, or who are HIV positive. Serology results obtained within 6 months prior to study entry are acceptable. If results cannot be obtained prior to study entry, a sample must be retained for later analysis. This stored sample will be destroyed at the end of study.

Outcomes

Primary Outcomes

Comparing calculated glomerular filtration rate (GFR) at Month 3 (Week 12) to Baseline and by comparing the daily cyclosporine dose at Month 3 (Week 12) to Baseline.