Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
120
Countries
1
Sites
1
Kidney Transplant Recipient
To show the safety of halving maintenance IS in kidney transplant recipients that are of low allogenic risk
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Decision date (initial)
- 2026-05-17
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety
To show the safety of halving maintenance IS in kidney transplant recipients that are of low allogenic risk
Secondary objectives 3
- To show the safety of halving maintenance IS in kidney transplant recipients that are of low-risk.
- To assess the molecular correlates of alloreactivity
- To better quantify the differences in outcomes in the different allogenic risk categories.
Conditions and MedDRA coding
Kidney Transplant Recipient
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10077912 | Renal retransplantation | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Kidney transplant recipient
- Transplanted with a deceased donor kidney transplant within the last three months
- 18 years of age or older
- Tacrolimus-based immunosuppression
- CCRS category 1 or 4 (low or high risk respectively)
Exclusion criteria 10
- Multi organ transplant recipient
- Recipient is Epstein–Barr virus (EBV) sero-negative
- Recipient is cytomegalovirus (CMV) sero-negative and receives an organ from a CMV positive donor
- Active hepatitis B/C infection
- DSA MFI>1000
- Recipient has been a participant of a trial less than three months before enrolment
- CCRS category 2 or 3 (moderate low or moderate high risk respectively)
- Biopsy-proven rejection Banff ≥1A
- Pregnancy
- Unable to sign the informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Biopsy-proven rejection (Banff ≥1A) within the one-year intervention phase (V5-V17)
- Occurrence of dnDSAs (MFI>1000) within the one-year intervention phase (V5-V17)
Secondary endpoints 5
- eGFR levels after the one-year intervention phase
- Incidence of ddcfDNA > 1% within the one-year intervention phase
- Graft loss within the one-year intervention phase: Graft loss is defined as permanent (>3 months) return to dialysis or re-transplantation.
- Incidence rate of infections within the one-year intervention phase
- Mortality within the one-year intervention phase
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
NULOJIX 250 mg powder for concentrate for solution for infusion
PRD2333424 · Product
- Active substance
- Belatacept
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 6 mg/kg milligram(s)/kilogram
- Max total dose
- 6 mg/kg milligram(s)/kilogram
- Max treatment duration
- 11 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA28 — -
- Marketing authorisation
- EU/1/11/694/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Starting from the end of the screening phase (M3), patients will undergo a two-month tacrolimus to belatacept conversion phase (M3-M5). During the conversion phase patients will receive belatacept (6mg/kg BW) infusions every two weeks. Concurrently tacrolimus treatment will be tapered down from 100% at day one of the conversion phase (D1), to 50% at D15, 25% at D22, and 0% at D29, similar to a previously published conversion regimen (Budde et al. 2021). Following conversion to belatacept based IS, the standard dose group (SDI) will receive 6mg/kg body weight (BW) every month as per label (European Medicines Agency 2023) together with the prescribed 2,000mg mycophenolate mofetil and 5mg prednisolone. The half-dose group will receive the same belatacept dose but only every two months (in combination with 1000mg mycophenolate mofetil and 2.5mg prednisolone), which has been shown at 5mg/kg BW to be safe in low-risk patients after the first year (Badell et al. 2021). Participants in the high-risk group will receive the SDI, while the low-risk group will be randomised into a control and treatment group receiving the SDI and HDI respectively.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of Nephrology and Dialysis, Department of Medicine III
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of Nephrology and Dialysis, Department of Medicine III
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 120 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_BaselineParameters_2025-525091-29-00 | 1 |
| Protocol (for publication) | D1_FlowChart_2025-525091-29-00 | 1 |
| Protocol (for publication) | D1_Protocol_2025-525091-29-00_redacted | 1.1 |
| Protocol (for publication) | D1_VisitAssessmentSchedule_2025-525091-29-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description_DE_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description_DE_TC | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Nulojix | 1 |
| Synopsis of the protocol (for publication) | D1_ProtocolSynopsis_DE_2025-525091-29-00_redacted | 1.1 |
| Synopsis of the protocol (for publication) | D1_ProtocolSynopsis_EN_2025-525091-29-00_redacted | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-17 | Austria | Acceptable 2026-04-30
|
2026-05-17 |