Tacrolimus After rATG and Infliximab Induction Immunosuppression (RIMINI)

• Status: Completed
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

International multicenter open-label single-arm confidence-interval-estimation based Phase II clinical trial, aiming to estimate a plausible range of the proportion of patients experiencing efficacy failure in the population, to provide evidence for efficacy and safety of the induction regimen with rATG and infliximab and a go/no go rule for further clinical development.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Dr. Petra Reinke
• Collaborator: Institut Klinické a Experimentální Medicíny
• Treatments: Antibodies; Antilymphocyte Serum; Immunoglobulins; Immunoglobulins, Intravenous; Infliximab; Prednisolone; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

1. Primary deceased-donor or living-donor kidney transplantation XML File Identifier:

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2. Men and women (recipient) age >18 years and <70 years

3. Panel reactive antibody frequency/ calculated panel reactive antibody frequency (peak PRA/cPRA) <20%

4. Written informed consent

5. Diagnosis of end stage renal disease

6. Women of Childbearing Potential (WOCBP) must be using a highly effective method of contraception (Pearl-Index < 1) to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of clinical trial. Male participants with pregnant or nonpregnant WOCBP partner must use condoms.

Exclusion Criteria:

1. Previous transplantation

2. Combined kidney transplantation with other organ

3. Subjects receiving an allograft from a donor older than 65 years with elevated serum creatinine levels and/or treated diabetes.

4. Immunosuppressive therapy up to 6 months before transplantation

5. Planned induction therapy with depletion agents

6. EBV seronegativity

7. HIV positivity

8. Leukopenia < 3000 cells per microliter, thrombocytopenia < 100 000 cells per microliter

9. Biological therapy history with ATG, OKT3, anti TNF agents

10. Tuberculosis history

11. Cancer history (skin non-melanoma cancer excluded)

12. Anti HCV positivity, HBsAg positivity or HBV DNA positivity

13. Detectable donor specific antibodies (DSA) by solid phase assay (Luminex®)

14. Subjects with a known hypersensibility to any of the drugs used in this protocol

15. Subjects who have used any investigational drug within 30 days prior to enrolment in this clinical trial

16. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period, women who are pregnant or breastfeeding or women with a positive pregnancy test on enrolment

17. Subjects who are legally detained in an official institution

18. All contraindications against study medication (including auxiliary substances)

19. Interactions with study medication

20. Current treatment with one of the following substances:

cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine, rituximab, prednisone

21. Patients unwilling to consent to saving and propagation of pseudonymized medical data and/or biological samples for study reasons

22. Chronic heart failure (NYHA III, IV) at transplantation

23. Participation in other clinical trials (pharmaceutical trials)

24. persons dependent of the sponsor, investigator or investigative site

25. positive Quantiferon test (for TBC)

26. live vaccine treatment 30 days prior to enrolment in this clinical trial