Multi-center, open-label, prospective, randomized, parallel group study investigating a CNI-free regimen with Myfortic® and Certican® in comparison to standard therapy with Myfortic® and a calcineurin inhibitor (Sandimmun® Optoral or Prograf®) in stable renal transplant patients - APOLLO

• Conditions: maintenance kidney transplantation; MedDRA version: M15Level: LLTClassification code 10023438

• Registration Number: EUCTR2005-001013-18-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-28
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Males or females, aged >18 years
2. Maintenance renal transplant recipients at least 6 months and not more than 10 years post-transplantation
3. Patients with a serum creatinine < 2,5 mg/dL stable for at least 3 month (according to the investigator)
4. Patients receiving Myfortic® (Myfortic dose >/= 720 mg/d) and a CNI (Sandimmun® Optoral or Prograf®) with or without corticosteroids as part of their immunosuppressive regimen for at least 1 month before baseline.
5. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility (see also chapter 8.2).
6. 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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. More than one previous renal transplantation
2. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
3. Patient with proteinuria > 1000 mg/day at baseline
4. Patients with hypersensitivity to Certican®, Sandimmun® Optoral, Prograf®, mycophenolic acid, or other components of the formulation (e.g. lactose; see also SPCs)
5. Patients who have received an investigational drug within four weeks prior to baseline
6. Patients who suffered from severe rejection (more than or equal to BANFF II acute rejection), recurrent acute rejection, or steroid resistant rejection within 3 months of enrollment in this trial (baseline)
7. Patients with thrombocytopenia (platelets < 100,000/mm³), with an absolute neutrophil count of < 1,500/mm³ or leucopenia (leucocytes < 4,000/mm³), or hemoglobin < 8 g/dL
8. Abnormal physical or laboratory findings of clinical significance within 2 weeks of study inclusion (baseline) which at investigator discretion would interfere with the objectives of the study
9. Patients with symptoms of significant somatic or 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
10. Patients with a history of malignancy during the last five years, except squamos or basal cell carcinoma of the skin
11. Patients who are HIV positive, or Hepatitis C-, or Hepatitis B surface antigen positive
12. Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL)
13. Females of childbearing potential who are planning to become pregnant, who are pregnant or lactating and/or who are unwilling to use effective means of contraception (see also chapter 8.2)
14. 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
15. Evidence of drug or alcohol abuse

Study & Design

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