A randomized, multi-center, parallel-group, open-label study to evaluate the therapeutical benefit of an initially intensified dosing regimen of Myfortic® vs. a standard dosing regimen of Myfortic® in combination with Neoral® and Corticosteroids in de novo renal transplant patients

• Conditions: Prophylaxis of rejection in recipients of first or second cadaveric, living unrelated or living related kidney transplants

• Registration Number: EUCTR2006-003633-32-SE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

1. Males or females, aged between 18 and 65 years
2. Recipients of first or second cadaveric, living unrelated or living related kidney transplants
3. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at Baseline (Visit 1), and are required to practice an approved method of birth control for the duration of the study and for a period of 3 months following discontinuation of study medication, even where there has been a history of infertility
4. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained

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

1. Graft loss due to immunological reasons in the first year after the first transplantation (in case of secondary transplantation)
2. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
3. Patients receiving a kidney from a non-heart beating donor
4. Patients who are recipients of A-B-O incompatible transplants
5. Patients with a current peak PRA of > 10%
6. Patients with already existing antibodies against the HLA-type of the receiving transplant
7. Patients with any known hypersensitivity to mycophenolic acid or cyclosporine micro-emulsion, or other components of the formulations (e.g. lactose, see also SmPCs)
8. Use of other investigational drugs or a non-protocol immunosuppressant at randomization, or within 30 days or 5 half-lives prior to randomization, whichever is longer
9. Patients with thrombocytopenia (platelets < 100,000/mm³), with an absolute neutrophil count of < 2,000/mm³ or leucopenia (leucocytes < 3,000/mm³), or hemoglobin < 6 g/dL
10. Patients with symptoms of significant mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent
11. Patients with a history of malignancy during the last five years, except squamous or basal cell carcinoma of the skin
12. Patients who are HIV positive or Hepatitis B surface antigen positive.
13. Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL)
14. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception (see also section 8.2)
15. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a 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 amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or 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, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, 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. Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study
17. Evidence of drug or alcohol abuse
18. Patients receiving drugs known as strong inhibitors or inducers of CsA and/or Myfortic® drug metabolism (for drug interactions see Appendix 3 to this protocol).
19. Patients with chronic bowel inflammatory disease.

Study & Design

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