Clinical trial • Phase IV • Nephrology|Immunology
belatacept for Kidney transplant recipient
Phase IV trial of belatacept for Kidney transplant recipient.
Overview
- Trial Therapeutic Area
- Nephrology|Immunology
- Trial Disease
- Kidney transplant recipient
- Trial Stage
- Phase IV
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 17-02-2026
- First CTIS Authorization Date
- 17-05-2026
Trial design
Randomised, open-label, control and treatment groups: standard dose immunosuppression (sdi) vs half-dose immunosuppression (hdi). belatacept regimen: conversion phase: belatacept 6 mg/kg bw infusions every two weeks during tacrolimus taper (m3-m5); following conversion, sdi receives belatacept 6 mg/kg bw every month plus mycophenolate mofetil 2000 mg and prednisolone 5 mg. hdi receives belatacept 6 mg/kg bw every two months plus mycophenolate mofetil 1000 mg and prednisolone 2.5 mg. high-risk group receive sdi; low-risk group are randomised between sdi (control) and hdi (treatment). Phase IV trial in Austria.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Control and treatment groups: Standard dose immunosuppression (SDI) vs Half-dose immunosuppression (HDI). Belatacept regimen: conversion phase: belatacept 6 mg/kg BW infusions every two weeks during tacrolimus taper (M3-M5); following conversion, SDI receives belatacept 6 mg/kg BW every month plus mycophenolate mofetil 2000 mg and prednisolone 5 mg. HDI receives belatacept 6 mg/kg BW every two months plus mycophenolate mofetil 1000 mg and prednisolone 2.5 mg. High-risk group receive SDI; low-risk group are randomised between SDI (control) and HDI (treatment).
- Target Sample Size
- 120
- Trial Duration For Participant
- 365
Stratification factors
- CCRS category (allogenic risk)
Eligibility
Recruits 120 Vulnerable populations not selected (isVulnerablePopulationSelected:false). Only adults (>=18 years) are eligible. 'Unable to sign the informed consent' is listed as an exclusion. No provisions for assent or enrolment of minors are described..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- Vulnerable populations not selected (isVulnerablePopulationSelected:false). Only adults (>=18 years) are eligible. 'Unable to sign the informed consent' is listed as an exclusion. No provisions for assent or enrolment of minors are described.
Inclusion criteria
- {"criterion_text":"- Kidney transplant recipient"}
- {"criterion_text":"- Transplanted with a deceased donor kidney transplant within the last three months"}
- {"criterion_text":"- 18 years of age or older"}
- {"criterion_text":"- Tacrolimus-based immunosuppression"}
- {"criterion_text":"- CCRS category 1 or 4 (low or high risk respectively)"}
Exclusion criteria
- {"criterion_text":"- Multi organ transplant recipient"}
- {"criterion_text":"- Unable to sign the informed consent"}
- {"criterion_text":"- Recipient is Epstein–Barr virus (EBV) sero-negative"}
- {"criterion_text":"- Recipient is cytomegalovirus (CMV) sero-negative and receives an organ from a CMV positive donor"}
- {"criterion_text":"- Active hepatitis B/C infection"}
- {"criterion_text":"- DSA MFI>1000"}
- {"criterion_text":"- Recipient has been a participant of a trial less than three months before enrolment"}
- {"criterion_text":"- CCRS category 2 or 3 (moderate low or moderate high risk respectively)"}
- {"criterion_text":"- Biopsy-proven rejection Banff ≥1A"}
- {"criterion_text":"- Pregnancy"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Biopsy-proven rejection (Banff ≥1A) within the one-year intervention phase (V5-V17)","definition_or_measurement_approach":"Biopsy-proven rejection defined by Banff classification grade ≥1A; assessed by graft biopsy during the one-year intervention phase (V5-V17)."}
- {"endpoint_text":"- Occurrence of dnDSAs (MFI>1000) within the one-year intervention phase (V5-V17)","definition_or_measurement_approach":"De novo donor-specific antibodies (dnDSAs) defined as MFI>1000, measured during the one-year intervention phase (V5-V17)."}
Secondary endpoints
- {"endpoint_text":"- eGFR levels after the one-year intervention phase","definition_or_measurement_approach":"Estimated glomerular filtration rate (eGFR) measured after the one-year intervention phase."}
- {"endpoint_text":"- Incidence of ddcfDNA > 1% within the one-year intervention phase","definition_or_measurement_approach":"Donor-derived cell-free DNA (ddcfDNA) incidence defined as >1%, measured during the one-year intervention phase."}
- {"endpoint_text":"- Graft loss within the one-year intervention phase: Graft loss is defined as permanent (>3 months) return to dialysis or re-transplantation.","definition_or_measurement_approach":"Graft loss defined as permanent (>3 months) return to dialysis or re-transplantation, assessed during the one-year intervention phase."}
- {"endpoint_text":"- Incidence rate of infections within the one-year intervention phase","definition_or_measurement_approach":"Incidence rate of infections recorded during the one-year intervention phase."}
- {"endpoint_text":"- Mortality within the one-year intervention phase","definition_or_measurement_approach":"All-cause mortality occurring within the one-year intervention phase."}
Recruitment
- Planned Sample Size
- 120
- Recruitment Window Months
- 49
- Consent Approach
- Informed consent obtained from participants themselves (adults >=18). 'Unable to sign the informed consent' is an exclusion. Subject information and informed consent form documents are provided (documents include German versions: L1_SIS and ICF description_DE). No assent procedures or minor/paediatric consent described; languages explicitly available include German (DE) as per provided document titles.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 120
Austria
- Earliest CTIS Part Ii Submission Date
- 25-04-2026
- Latest Decision Or Authorization Date
- 17-05-2026
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 120
Sites
- Site Name
- Medical University Of Vienna, Waehringer Guertel 18-20, Alsergrund
- Department Name
- Division of Nephrology and Dialysis, Department of Medicine III
- Principal Investigator Name
- Rainer Oberbauer
- Principal Investigator Email
- rainer.oberbauer@meduniwien.ac.at
- Contact Person Name
- Rainer Oberbauer
- Contact Person Email
- rainer.oberbauer@meduniwien.ac.at
Sponsor
Primary sponsor
- Full Name
- Medical University Of Vienna
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Austria
Investigational products
- Investigational Product Name
- NULOJIX 250 mg powder for concentrate for solution for infusion
- Active Substance
- belatacept
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation EU/1/11/694/001)
- Starting Dose
- 6 mg/kg
- Dose Levels
- Conversion: 6 mg/kg every 2 weeks during conversion (M3-M5); Standard: 6 mg/kg every month (with mycophenolate mofetil 2000 mg and prednisolone 5 mg); Half-dose: 6 mg/kg every 2 months (with mycophenolate mofetil 1000 mg and prednisolone 2.5 mg).
- Frequency
- Every 2 weeks (conversion), then monthly (standard), every 2 months (half-dose)
- Maximum Dose
- 6 mg/kg
- Combination Treatment
- Yes
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