A six-month, prospective, multicentre, open-label, parallel-group, randomized study of the safety, tolerability and efficacy of myfortic (ERL080) with Simulect, cortocosteroids and two different levels of tacrolimus in de novo renal transplant recipients.

• Conditions: de novo renal transplant

• Registration Number: EUCTR2005-001518-42-GB
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-27
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

1.Male or female patients between 18 and 70 years of age
2.Male or female patients who are primary cadaveric, living unrelated or non- Human leukocyte antigen (HLA) identical living related donor renal transplant recipients
3.The renal cold ischemic time (CIT) must be <30 hours
4.The age of the donor must be between 10 and 65 years
5.The patient has given written informed consent to participate in the study

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

Patients meeting any of the following criteria at baseline will be excluded from study participation.
1.Patients who have previously received an organ transplant
2.Patients who are recipients of a multiple organ transplants
3.Recipients of non heart-beating donor organs
4.ABO incompatibility against the donor
5.Patients with panel reactive antibodies (PRA) of >20% at most recent assessment prior to transplantation
6.Patients who are known to have a positive hepatitis C serology, who are human immunodeficiency virus (HIV) or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to first dose of myfortic® are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded
7.Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of <1,500/mm3, and/or leukocytopenia (< 2,500/mm3), or hemoglobin < 6g/dL prior to randomization.
8.Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
9.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
10.Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication, and/or presence of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus
11.Patients with clinically significant systemic infection requiring continued therapy
12.Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin
13.Abnormal physical or laboratory findings of clinical significance within 2 weeks prior to first dose of myfortic® which at investigators discretion would interfere with the objectives of the study
14.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin (hCG) laboratory test
15.Women of child-bearing potential (WOCBP), defined as all women whose career, lifestyle, or sexual orientation precludes intercourse witha male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous with serum FSH levels >40mIU/m or 6 weeks post surgical bilateral oophorectomy withor without hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, spoge, cervical cap). Periodic abstinence (e.g. calendar, ovulation, symtothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation.
16. Patients with symptoms of significant somatic or mental illness. Unresolved history of drug or alcohol abuse
17.Inability to cooperate or communic

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified