Everolimus in de Novo Heart Transplant Recipients

NCT01017029 | Completed Phase 4 Results

• 2 other identifiers: CRAD001AIT162009-011008-43
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Cardiac Transplantation

Outcome Measures

Primary Outcomes (1)

• Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group

  Comparison of 6-month cumulative incidence of safety composite endpoint (wound healing delay) related to initial transplant surgery, pleural/pericardial effusions and occurrence of acute renal insufficiency, defined as estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2, between delayed everolimus arm and immediate everolimus arm

  6 months

Secondary Outcomes (5)

• Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group

  6 months

• Hazard Cox's Model Analysis of Pericardial/Pleural Effusions

  6 months

• Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group

  6 months

• Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group

  6 months

• Participants With at Least One Occurrence of Composite Treatment Failure Events

  6 months

Study Arms (2)

Immediate introduction of everolimus

ACTIVE COMPARATOR

Drug: Everolimus

Delayed introduction of everolimus

EXPERIMENTAL

delayed introduction) + Cyclosporin + steroids

Drug: Mycophenolate mofetil + Everolimus

Interventions

Everolimus DRUG

Immediate introduction of everolimus

Mycophenolate mofetil + Everolimus DRUG

Delayed introduction of everolimus

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (12)

Novartis Investigative Site

Bari, BA, 70124, Italy

Location

Novartis Investigative Site

Bologna, BO, 40138, Italy

Location

Novartis Investigative Site

Cagliari, CA, 09134, Italy

Location

Novartis Investigative Site

Milan, MI, 20162, Italy

Location

Novartis Investigative Site

Padua, PD, 35128, Italy

Location

Novartis Investigative Site

Pavia, PV, 27100, Italy

Location

Novartis Investigative Site

Roma, RM, 00152, Italy

Location

Novartis Investigative Site

Siena, SI, 53100, Italy

Location

Novartis Investigative Site

Torino, TO, 10126, Italy

Location

Novartis Investigative Site

Udine, UD, 33100, Italy

Location

Novartis Investigative Site

Verona, VR, 37126, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Related Publications (1)

• Potena L, Pellegrini C, Grigioni F, Amarelli C, Livi U, Maccherini M, Masciocco G, Faggian G, Lilla Della Monica P, Gerosa G, Marraudino N, Corda M, Boffini M; EVERHEART Investigators. Optimizing the Safety Profile of Everolimus by Delayed Initiation in De Novo Heart Transplant Recipients: Results of the Prospective Randomized Study EVERHEART. Transplantation. 2018 Mar;102(3):493-501. doi: 10.1097/TP.0000000000001945.

  PMID: 28930797 DERIVED

MeSH Terms

Interventions

Everolimus; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Novartis
• Organization: Pharmaceuticals

+1(862)778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 20, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 12, 2015
• Results First Posted: December 18, 2014

Record last verified: 2014-12

Locations

IT (12)