Study investigating a standard treatment in kidney transplant patients versus a treatment with Certican® in combination with Cyclosporin A or Tacrolimus
- Conditions
- Kidney transplantationMedDRA version: 14.1Level: LLTClassification code 10054990Term: Immunodeficiency secondary to organ transplantationSystem Organ Class: 100000004870Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2011-005238-21-FR
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 612
1.Male or female renal allograft recipients at least 18 years old
2.Patient who has received a primary or secondary kidney transplant from a deceased or living unrelated-/related donor
3.Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
4.Recipient of a kidney allograft with a cold ischemia time (CIT) < 30 hours
5.Female patients who are menstruating and capable of becoming pregnant must have a negative pregnancy test prior to study enrollment
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1.Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
2.Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
3.Patients receiving a kidney from a non-heart beating donor
4.Patients who are recipients of A-B-0 incompatible transplants
5.Patients with a current Panel Reactive Antibody (PRA) level of > 20% (PRA levels within 4 months prior to enrollment) or patients with a positive Luminex test for any antigen of the donor
6.Patients with already existing antibodies against the HLA-type of the receiving transplant (in the knowledge of the investigator at the time point of transplantation)
7.Patients with a known hypersensitivity/contraindication to any of the immunosuppressants or their classes, or to any of the excipients
8.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, 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 < 8 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, renal cell carcinoma = T1N0M0, prostate adenocarcinoma = T1N0M0 and adenocarcinoma of the thyroid
12.Patients who are HIV positive
13.Patient with uncontrolled hypercholesterolemia or hypertriglyceridemia
14.Evidence of drug or alcohol abuse
15.Women
owho are pregnant or breast feeding
owho are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index <1) during and up to at least 8 weeks after the end of treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method