Study to compare a tacrolimus Hexal® based regimen versus a Prograf® based regimen in renal transplantatio

Phase 1

• Conditions: renal transplantation; MedDRA version: 18.0Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2011-003795-36-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-10
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

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

Inclusion Criteria

1. Male or female renal allograft recipients aged between 18 and 64 years
2. Patients who have received a primary or secondary kidney transplant from a de novo deceased, living unrelated or living related donor aged < 65 years
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) < 24 hours
5. Female patients 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 81
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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-O incompatible transplants
5. Patients with a current Panel Reactive Antibody (PRA) level of > 20% PRA levels within 4 months prior to enrollment are acceptable
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 any known hypersensitivity to tacrolimus or mycophenolic acid, to drugs with similar chemical structures or other components of the formulations (e.g. lactose, see also SmPCs)
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
12. Patients who are HIV positive
13. Patient who received an allograft from a Hepatitis B surface Antigen (HBsAg) or a
Hepatitis C Virus (HCV) positive donor
14. HBsAg and/or a HCV positive patient with an abnormal liver enzyme profile (ALT or AST > 3 times UNL). Viral serology results obtained within 6 months prior to enrollment are acceptable
15. Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST or ALT > 3 times UNL)
16. Evidence of drug or alcohol abuse
17. Patients, who have already been randomized into this trial earlier must not be included a second time.
18. Women
o who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml))
o who 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 6 weeks after the end of treatment. A negative pregnancy test (serum) for all women entering menarche is required with sufficient lead time before inclusion
*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
**examples of particularly reliable methods with Pearl Index (PI) <1, according to guidelines of Deutsche Gesellschaft für Gynäkologie und Geburtshilfe:
? Combination pill with estrogen and gestagen (no mini-pill, PI=0.1-0.9)
? Vaginal ring (PI=0.65 uncorr.; 0.4 corr.)
? Contraceptive patch (PI= 0.72 uncorr.; 0.9 corr.)
? Estrogen-free ovulation inhibitors (PI=0.14)
? Progestin-containing contraceptives (PI=0-0.08)
? Injectable 3-month depot progestins (PI=0.3-1.4; 0.88 corr.)
? Intra-uterine progestine device (PI=0.16)
? Total abstinence (when this is in line with the preferred and usual lifest

Study & Design

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