Status:
COMPLETED
Tacrolimus After rATG and Infliximab Induction Immunosuppression (RIMINI)
Lead Sponsor:
Prof. Dr. Petra Reinke
Collaborating Sponsors:
Institut Klinické a Experimentální Medicíny
Conditions:
Renal Transplant Rejection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 f...
Detailed Description
A total of 75 patients will receive the proposed induction regimen, with expected 68 completers accounting for drop-outs and non-compliances with the protocol. If up to 27 out of the 68 completers exp...
Eligibility Criteria
Inclusion
- Primary deceased-donor or living-donor kidney transplantation XML File Identifier: CJub4EkHas0e/mXDp2mGyZzEe9E= Page 22/33
- Men and women (recipient) age \>18 years and \<70 years
- Panel reactive antibody frequency/ calculated panel reactive antibody frequency (peak PRA/cPRA) \<20%
- Written informed consent
- Diagnosis of end stage renal disease
- 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
- Previous transplantation
- Combined kidney transplantation with other organ
- Subjects receiving an allograft from a donor older than 65 years with elevated serum creatinine levels and/or treated diabetes.
- Immunosuppressive therapy up to 6 months before transplantation
- Planned induction therapy with depletion agents
- EBV seronegativity
- HIV positivity
- Leukopenia \< 3000 cells per microliter, thrombocytopenia \< 100 000 cells per microliter
- Biological therapy history with ATG, OKT3, anti TNF agents
- Tuberculosis history
- Cancer history (skin non-melanoma cancer excluded)
- Anti HCV positivity, HBsAg positivity or HBV DNA positivity
- Detectable donor specific antibodies (DSA) by solid phase assay (Luminex®)
- Subjects with a known hypersensibility to any of the drugs used in this protocol
- Subjects who have used any investigational drug within 30 days prior to enrolment in this clinical trial
- 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
- Subjects who are legally detained in an official institution
- All contraindications against study medication (including auxiliary substances)
- Interactions with study medication
- Current treatment with one of the following substances:
- cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine, rituximab, prednisone
- Patients unwilling to consent to saving and propagation of pseudonymized medical data and/or biological samples for study reasons
- Chronic heart failure (NYHA III, IV) at transplantation
- Participation in other clinical trials (pharmaceutical trials)
- persons dependent of the sponsor, investigator or investigative site
- positive Quantiferon test (for TBC)
- live vaccine treatment 30 days prior to enrolment in this clinical trial
Key Trial Info
Start Date :
December 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04114188
Start Date
December 15 2016
End Date
December 31 2020
Last Update
January 29 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charité University Medicine Berlin
Berlin, Germany, 13353