Assessment of long term minimization of immunosuppression in transplanted patients.

Tacrolimus after rATG and infliximab induction immunosuppression (RIMINI)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005346-58-DE

Enrollment

Registered

2016-08-05

Start date

2016-10-05

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rejection rate, graft loss or poor graft function defined as eGFR<40 ml/min in patients with kidney transplantation. MedDRA version: 20.0 Level: PT Classification code 10023439 Term: Kidney transplant rejection System Organ Class: 10021428 - Immune system disorders

Interventions

Product Name: Thymoglobulin Pharmaceutical Form: Powder for solution for infusion Other descriptive name: ANTITHYMOCYTE IMMUNOGLOBULIN Concentration unit: mg/ml milligram(s)/millilitre Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Primary deceased-donor or living-donor kidney transplantation 2. Men and women (recipient) age >18 years and 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 non-pregnant WOCBP partner must use condoms. 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) Composite endpoint of efficacy failure of the induction regimen defined as occurrence of any of the following individual outcomes up to 12 months post transplantation (start of follow up at transplantation): acute rejection, graft loss or poor graft function defined as eGFR<40 ml/min.;Secondary Objective: 1) Prevalence of biomarker signatures of rejection and tolerance at 6 and 12 months 2) Incidence of death by 12 months post-transplantation 3) Incidence of graft loss by 12 months post-transplantation 4) Incidence of metabolic and cardiovascular co-morbidity by 12 months post-transplantation (post-transplant diabetes mellitus, dyslipidemia, hypertension, myocardial infarction, stroke, peripheral vascular disease) 5) Proportion of subjects who remain on tacrolimus/steroids therapy at 12 months post-transplantation 6) Incidence of acute and chronic lesions assessed by the Banff 07 score in protocol biopsy at 12months post-transplantation 7) Incidence of discontinuation of study treatment 8) DSA at 12M 9) Overall safety of tacrolimus/steroids therapy immunosuppressive regimen defined as viral and bacterial infections, malignancies and autoimmunity. 10) Health-related quality of life using EQ5D-5L and SF-36v2 questionnaires at baseline, M1, M3, M6, and M12 ;Primary end point(s): 1) Composite endpoint of efficacy failure of the induction regimen defined as occurrence of any of the following individual outcomes up to 12 months post transplantation (start of follow up at transplantation): acute rejection, graft loss or poor graft function defined as eGFR<40 ml/min.;Timepoint(s) of evaluation of this end point: Up to 12 months post transplantation.	—

Measure

Time frame

Main Objective: 1) Composite endpoint of efficacy failure of the induction regimen defined as occurrence of any of the following individual outcomes up to 12 months post transplantation (start of follow up at transplantation): acute rejection, graft loss or poor graft function defined as eGFR<40 ml/min.;Secondary Objective: 1) Prevalence of biomarker signatures of rejection and tolerance at 6 and 12 months 2) Incidence of death by 12 months post-transplantation 3) Incidence of graft loss by 12 months post-transplantation 4) Incidence of metabolic and cardiovascular co-morbidity by 12 months post-transplantation (post-transplant diabetes mellitus, dyslipidemia, hypertension, myocardial infarction, stroke, peripheral vascular disease) 5) Proportion of subjects who remain on tacrolimus/steroids therapy at 12 months post-transplantation 6) Incidence of acute and chronic lesions assessed by the Banff 07 score in protocol biopsy at 12months post-transplantation 7) Incidence of discontinuation of study treatment 8) DSA at 12M 9) Overall safety of tacrolimus/steroids therapy immunosuppressive regimen defined as viral and bacterial infections, malignancies and autoimmunity. 10) Health-related quality of life using EQ5D-5L and SF-36v2 questionnaires at baseline, M1, M3, M6, and M12 ;Primary end point(s): 1) Composite endpoint of efficacy failure of the induction regimen defined as occurrence of any of the following individual outcomes up to 12 months post transplantation (start of follow up at transplantation): acute rejection, graft loss or poor graft function defined as eGFR<40 ml/min.;Timepoint(s) of evaluation of this end point: Up to 12 months post transplantation.

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Secondary

Measure	Time frame
Secondary end point(s): 1) Prevalence of biomarker signatures of rejection and tolerance at 6 and 12 months 2) Incidence of death by 12 months post-transplantation 3) Incidence of graft loss by 12 months post-transplantation 4) Incidence of metabolic and cardiovascular co-morbidity by 12 months post-transplantation (post-transplant diabetes mellitus, dyslipidemia, hypertension, myocardial infarction, stroke, peripheral vascular disease) 5) Proportion of subjects who remain on tacrolimus/steroids therapy at 12 months post-transplantation 6) Incidence of acute and chronic lesions assessed by the Banff 07 score in protocol biopsy at 12months post-transplantation 7) Incidence of discontinuation of study treatment 8) DSA at 12M 9) Overall safety of tacrolimus/steroids therapy immunosuppressive regimen defined as viral and bacterial infections, malignancies and autoimmunity. 10) Health-related quality of life using EQ5D-5L and SF-36v2 questionnaires at baseline, M1, M3, M6, and M12 11) Assessment of patient-specific resource consumption using a trial specific questionnaire at initial discharge, M3, M6, M12, and in cases of repeated hospitalization;Timepoint(s) of evaluation of this end point: 1) at 6 and 12 months 2) up to 12 months 3) up to 12 months 4) up to 12 months 5) at 12 months 6) at 12 months 7) up to 12 months 8) at 12 months 9) up to 12 months 10) at baseline, 1 month, 3 months, 6 months and 12 months 11) at Initial discharge, 3 months, 6 months and 12 months	—

Measure

Time frame

Secondary end point(s): 1) Prevalence of biomarker signatures of rejection and tolerance at 6 and 12 months 2) Incidence of death by 12 months post-transplantation 3) Incidence of graft loss by 12 months post-transplantation 4) Incidence of metabolic and cardiovascular co-morbidity by 12 months post-transplantation (post-transplant diabetes mellitus, dyslipidemia, hypertension, myocardial infarction, stroke, peripheral vascular disease) 5) Proportion of subjects who remain on tacrolimus/steroids therapy at 12 months post-transplantation 6) Incidence of acute and chronic lesions assessed by the Banff 07 score in protocol biopsy at 12months post-transplantation 7) Incidence of discontinuation of study treatment 8) DSA at 12M 9) Overall safety of tacrolimus/steroids therapy immunosuppressive regimen defined as viral and bacterial infections, malignancies and autoimmunity. 10) Health-related quality of life using EQ5D-5L and SF-36v2 questionnaires at baseline, M1, M3, M6, and M12 11) Assessment of patient-specific resource consumption using a trial specific questionnaire at initial discharge, M3, M6, M12, and in cases of repeated hospitalization;Timepoint(s) of evaluation of this end point: 1) at 6 and 12 months 2) up to 12 months 3) up to 12 months 4) up to 12 months 5) at 12 months 6) at 12 months 7) up to 12 months 8) at 12 months 9) up to 12 months 10) at baseline, 1 month, 3 months, 6 months and 12 months 11) at Initial discharge, 3 months, 6 months and 12 months

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Countries

Czech Republic, Germany, Spain

Contacts

Public ContactProject manager

Charité - Universitätsmedizin Berlin

petra.reinke@charite.de

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026