Multi-center, open-label, prospective, randomized, parallel group, long-term study investigating a standard regimen in de novo kidney transplant patients versus a CNI-free regimen and a CNI-low dose regimen - HERAKLES

Phase 1

• Conditions: de novo kidney transplant patients; MedDRA version: 9.1Level: LLTClassification code 10023439Term: Kidney transplant rejection

• Registration Number: EUCTR2006-007021-32-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-17
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1.Males or females, aged 18 – 70 years
2.Recipients of de novo 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 6 weeks 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) 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.Patients receiving a kidney from a non-heart beating donor
4.Donor age: < 5 years or > 70 years
5.Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
6.Patients who are recipients of A-B-O incompatible transplants
7.Patients with a historical or current peak PRA of > 25% (current = 3 months)
8.Patients with already existing antibodies against the HLA-type of the receiving transplant
9.Patients with any known hypersensitivity to Simulect®, Certican®, mycophenolic acid, cyclosporine A, other drugs similar to Certican® (e.g., macrolides), or other components of the formulations (e.g. lactose)
10.Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1)
11.Patients with thrombocytopenia (platelets < 75,000/mm³), with an absolute neutrophil count of < 1,500/mm³ or leucopenia (leucocytes < 2,500/mm³), or hemoglobin < 6 g/dL
12.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
13.Patients with a history of malignancy during the last five years, except squamous or basal cell carcinoma of the skin
14.Patients who are HIV, HCV, or Hepatitis B surface antigen positive
15.Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL)
16.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
17.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
18.Evidence of drug or alcohol abuse
19.Patients receiving drugs known to strongly interact with CsA and/or everolimus according to the list provided in Appendix 3 to this protocol should be excluded, if in the opinion of the investigator this drug interaction interferes with the objectives of the study, namely a clinical meaningful potentiation of renal dysfunction and/or maintenance of adequate immunosuppressive drug levels

Study & Design

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