Roche trials database

Trial information

A Study of CellCept (Mycophenolate Mofetil) and Zenapax in Prevention of Acute Rejection in Heart Transplant Patients

Status:

Completed

Protocol number:

ML17910

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

An open-label pilot study of Zenapax in combination with CellCept and sirolimus on the prevention of acute rejection in patients receiving a heart transplant at risk of impaired kidney function

Brief summary:

This study will evaluate the efficacy and safety of intravenous Zenapax in combination with oral CellCept and oral sirolimus in patients receiving a heart transplant, and at risk of impaired kidney function. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 36.

Study phase:

IV

Study type:

Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Single group; Safety/efficacy study

Conditions:

• Heart Transplantation

Primary outcome:

1. Efficacy: Proportion of patients experiencing a biopsy-proven acute rejection episode at end of study\n\n

Key secondary outcomes:

1. Safety; Adverse events, laboratory abnormalities, opportunistic infections, patient and graft survival, malignancies\n

Inclusion criteria:

• adult patients >=18 years of age;
• single organ (heart) transplant recipients;
• at risk for post-transplant renal dysfunction.

Exclusion criteria:

• previous organ transplant;
• previous treatment with CellCept, Zenapax or sirolimus;
• positive for human immunodeficiency virus (HIV) infection;
• history of malignancy within the last 5 years, except localized and treated skin cancer, treated and without evident relapse.

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

February, 2004

Trial registration date:

20.12.2005

Date last updated:

10.06.2013

This trial was conducted at the following locations:

Spain

• BARCELONA
• EL PALMAR MURCIA
• HOSPITALET DE LLOBREGAT
• LA CORUNA
• MADRID
• OVIEDO
• PAMPLONA
• SANTANDER
• SEVILLA
• VALENCIA
• VALLADOLID

Link to trial result