12-month open label, randomized, multicenter study evaluating efficacy, safety and tolerability of oral AEB071 plus tacrolimus (converted to myfortic after 3 months), vs. myfortic plus tacrolimus in de novo renal transplant recipients - CAEB071A2203

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2005-003494-25-IT
• Date of registration: 13/07/2007
• Prospective Registration: No
• Primary sponsor: NOVARTIS FARMA
• Public title: 12-month open label, randomized, multicenter study evaluating efficacy, safety and tolerability of oral AEB071 plus tacrolimus (converted to myfortic after 3 months), vs. myfortic plus tacrolimus in de novo renal transplant recipients - CAEB071A2203
• Scientific title: 12-month open label, randomized, multicenter study evaluating efficacy, safety and tolerability of oral AEB071 plus tacrolimus (converted to myfortic after 3 months), vs. myfortic plus tacrolimus in de novo renal transplant recipients - CAEB071A2203
• Date of first enrolment: 04/07/2006
• Target sample size: 195
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003494-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: conversione da AEB071-tacrolimos a ABE071-Myfortic

Countries of recruitment

Germany, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Male and female patients of any race >=18 years old Recipients of a primary kidney transplant from a deceased, living unrelated or non-HLA identical living related donor Recipients of a kidney with a cold ischemic time (CIT) < 30 hours Recipients of a kidney from a donor 10-65 years old Recipients of a functional graft, i.e. producing a urinary output of >= 250 mL/12h (applicable only in patients with no residual urinary output from native kidneys), or a decrease in serum creatinine. Functionality must be achieved no later than 36h after transplantation. Patients able to swallow the first dose of oral study drug within 36 hours after graft reperfusion Patients willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Multi-organ transplant recipients Recipients of an organ from a non-heart beating donor Patients who are recipients of A-B-O incompatible transplants, all crossmatch positive transplants Use of other investigational drugs or a non-protocol immunosuppressant, including induction agents other than Simulect, at the time of enrollment, or within 30 days or 5 half-lives prior to enrollment, whichever is longer History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures Patients who are anti-HIV-positive, or HBsAg-positive. Anti-HCV-positive patients are excluded, except patients with spontaneously negative PCR-result (patients who cleared the virus under treatment remain excluded). Laboratory results obtained more than 6 months prior to study entry should be repeated within the first week after randomization. Patients who test positive for any of the viral indicators after randomization will be discontinued from study treatment. Recipients of a kidney from a donor who tests positive for HIV, HBsAg or anti-HCV Sensitized patients (most recent anti-HLA Class I Panel Reactive Antibodies >20% by a CDC-based assay or >50% by a Flow cytometry or ELISA-based assay) or patients identified otherwise to be at high immunological risk History of malignancy of any organ system, treated or untreated, within the past 5 years regardless of evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin (excised >=2 years prior to randomization) Patients with severe systemic infections, current or within the 2 weeks prior to randomization. Patients with QTc above normal range (cut-off 450 msec), or with a family history of long QT syndrome Patients with any history of significant coagulopathy or medical condition requiring longterm systemic anticoagulation after transplantation, which would interfere with obtaining biopsies. Aspirin treatment is allowed. Patients with an absolute neutrophil count of < 1,500/mm3, or absolute leukocytes count < 2,500/mm3. Evidence of severe liver disease, including abnormal liver profile (aspartate aminotransferase [AST], alanine aminotransferase [ALT] or total bilirubin > 3 times upper limit of normal [ULN]). Patients with a severe digestive system disorder (including functional disorders). Patients with any condition which is expected to prohibit full-dose myfortic therapy, or tacrolimus withdrawal in the maintenance period Patients with any surgical or medical condition, which in the opinion of the investigator, precludes enrollment in this trial Patients who are unlikely to comply with the study requirements or unable to cooperate or communicate with the investigator Pregnant or nursing (lactating) women, and women who might become pregnant during the study.


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

Health Condition(s) or Problem(s) studied

de novo renal transplant
MedDRA version: 9.1 Level: LLT Classification code 10038533 Term: Renal transplant

Intervention(s)

Product Name: AEB071
Product Code: AEB071A
Pharmaceutical Form: Capsule, hard
CAS Number: 425637-18-9
Current Sponsor code: AEB071A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: PROGRAF*30CPS 0,5MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tacrolimus
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-

Trade Name: PROGRAF*30CPS 5MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tacrolimus
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: MYFORTIC*50CPR RIV 360MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ACIDO MICOFENOLICO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 360-

Trade Name: PROGRAF*60CPS 1MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tacrolimus
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: PROGRAF*30CPS 0,5MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tacrolimus
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-

Trade Name: PROGRAF*30CPS 5MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tacrolimus
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: PROGRAF*60CPS 1MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tacrolimus
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: MYFORTIC*50CPR RIV 360MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ACIDO MICOFENOLICO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 360-

Primary Outcome(s)

Primary end point(s): Primary Efficacy Endpoint: The primary objective of the study is to demonstrate that in de novo renal transplant patients, non-inferior rates of efficacy failure, defined as the first occurrence of treated biopsy-proven acute rejection of grade >=1A, graft loss, death, or loss to follow-up, are achieved with at least one AEB071 regimen compared to the control regimen within 6 months of the initial dose of study medication.

Main Objective: The primary objective of the study is to demonstrate that in de novo renal transplant patients, at least one of the AEB071 treatment regimens is not inferior to the control treatment (myfortic + tacrolimus) within 6 months of the initial dose of study drug with respect to primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up.

Secondary Objective: The main secondary efficacy objective is to Evaluate the AEB071 regimens in comparison to the control arm with respect to primary efficacy failure at Month 3 post-transplant

Secondary ID(s)

CAEB071A2203

2005-003494-25-GB