SISTAR: Stratifying Immunosuppression to Allogenic Risk. A randomized, open label, assessor blinded, controlled, non-inferiority, safety study of half- vs standard dose immunosuppression in kidney transplant recipients with a well-matched donor.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-525091-29-00

Enrollment

120

Registered

2026-05-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-17

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

Conditions

Kidney Transplant Recipient

Brief summary

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)

Detailed description

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

Interventions

DRUGNULOJIX 250 mg powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Outcome results

None listed

Source: EU CTIS · Data processed: May 18, 2026