Phase 4 N=181 Randomized Prevention

Everolimus in de Novo Heart Transplant Recipients

Cardiac Transplantation

Bottom Line

View on ClinicalTrials.gov: NCT01017029 ↗

Enrolled (actual)

181

Serious AEs

36.5%

Results posted

Dec 2014

Primary outcome: Primary: Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group — 40; 30 participants — p=0.1043

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Everolimus (Drug); Mycophenolate mofetil + Everolimus (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group	40; 30	0.1043
SECONDARY Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group	10; 8; 1; 1; 30; 18	—
SECONDARY Hazard Cox's Model Analysis of Pericardial/Pleural Effusions	30; 18	0.0398 sig
SECONDARY Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group	41; 38; 37; 37; 34; 36	—
SECONDARY Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group	46; 63; 3; 6	0.0234 sig
SECONDARY Participants With at Least One Occurrence of Composite Treatment Failure Events	33; 26	0.1966

Summary

The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and/or pleural effusion and early acute renal insufficiency, as compared with immediate introduction of everolimus, in the firs six months after heart transplantation.

Eligibility Criteria

Inclusion criteria

Male or female cardiac transplant candidates 18-65 years of age undergoing primary heart transplantation.
Glomerular filtration rate (GFR by MDRD) ≥ 40 mL/min/1.73 m2 at randomization

Exclusion criteria

Patients who are recipients of multiple solid organ transplants
Patients who are HIV-positive or Hepatitis C positive (PCR only) or B-surface antigen positive;
Presence of Donor/Recipients serological mismatch for Hepatitis B or C;
Recipients of organ from donors positive for Hepatitis B-surface antigen;
Panel Reactive Antibodies (cytotoxicity method) > 30%.
Other protocol-defined inclusion/exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01017029). 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.