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Register:	EUCTR
Last refreshed on:	16 February 2015
Main ID:	EUCTR2004-001052-36-ES
Date of registration:	09/12/2005
Prospective Registration:	No
Primary sponsor:	Novartis Farmacéutica S.A
Public title:	A 12-month, multi-center, randomized, open-label non-inferiority study of renal function and efficacy comparing concentration-controlled Certican® (1.5 mg/day starting dose) with reduced Neoral® dose versus MMF with standard Neoral® dose in de novo heart transplant recipients. - RAD2411
Scientific title:	A 12-month, multi-center, randomized, open-label non-inferiority study of renal function and efficacy comparing concentration-controlled Certican® (1.5 mg/day starting dose) with reduced Neoral® dose versus MMF with standard Neoral® dose in de novo heart transplant recipients. - RAD2411
Date of first enrolment:	08/03/2005
Target sample size:	176
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001052-36
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: Double blind: Parallel group: yes Cross over: Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: Other:
Phase:

Countries of recruitment
Germany	Italy	Spain

Contacts

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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
•Male or female cardiac recipients 18-65 years of age undergoing primary heart transplantation.
•Patients who have given written informed consent to participate in the study.
•Calculated creatinine clearance (by Cockroft-Gault) = 50 mL/min at screening

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Patients with platelet count <50,000/mm3 at the evaluation before randomization.
•Patients who are recipients of multiple solid organ transplants.
•Patients receiving induction therapy which is not standard per local practice
•Patients with clinically significant systemic infection.
•Patients receiving investigational agents in the 30 days prior to study entry.
•Known hypersensitivity to drugs of this class.
•Donor > 60 years and/or with known donor heart disease
•Patients with PRA >20%.
•Treatment with strong inducers or inhibitors of cytochrome P450 3A4.
•Cold ischemic time >6 hours.
•Unable to take oral medication.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic cardiac transplant in combination with ciclosporin for microemulsion and corticosteroids.
MedDRA version: 7.0 Level: LLT Classification code 10050432

Intervention(s)

Trade Name: Cellcept
Product Name: Cellcept
Pharmaceutical Form: Tablet
INN or Proposed INN: Micofenolato de sodio
CAS Number: 24280-93-1
Current Sponsor code: Cellept
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 500-

Trade Name: certican 0.25 mg tablets
Product Name: certican
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus
Current Sponsor code: RAD001
Other descriptive name: CERTICAN
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 0,25-

Trade Name: certican 0.75 mg tablets
Product Name: certican
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus

Trade Name: certican 0.5 mg tablets
Product Name: certican
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus

Primary Outcome(s)

Primary end point(s): •To demonstrate that comparable (non-inferior) renal function (calculated creatinine clearance according to Cockroft-Gault) is achieved in cohorts of de novo heart recipients treated with Certican/reduced dose Neoral/steroids versus MMF/standard dose Neoral/steroids after 6 months post transplantation.

Main Objective: •To demonstrate that comparable (non-inferior) renal function (calculated creatinine clearance according to Cockroft-Gault) is achieved in cohorts of de novo heart recipients treated with Certican/reduced dose Neoral/steroids versus MMF/standard dose Neoral/steroids 6 months post transplantation.

Secondary Objective: •To assess if comparable rates of biopsy-proven acute rejection (BPAR) of ISHLT grade =3A are achieved in the Certican treatment arm vs MMF treatment arm at 6 and 12 months.
•Renal function (crea clearance) at 12 months
•Assessment of composite efficacy failure, incidence of acute rejection with hemodynamic compromise, proteinuria, Aes/infections, SAEs, premature study (treatment)discontinuations, all at 6 and 12 months
•Others

Secondary Outcome(s)

Secondary ID(s)

2004-001052-36-IT

CRAD001A2411

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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