Corline Biomedical Achieves 60-Month Safety Confirmation for Renaparin in Kidney Transplantation

Five-year follow-up data from Corline Biomedical's STARS-nob study reinforce the Phase 1 safety profile of Renaparin® and provide the evidentiary foundation the company needs to advance into a powered interventional trial, a sequence that regulatory leads preparing IND/CTA packages for novel organ-preservation biologics will recognise as a credible development pathway.

The STARS-nob study enrolled 21 patients: 16 from the original RENAPAIR 01 Phase 1 cohort and five recipients of contralateral paired kidneys, organs from the same donor not treated with Renaparin®, representing the closest available biological comparator. At 60 months, all Renaparin®-treated kidneys retained functional grafts. Among the five matched pairs, the treated kidney showed superior eGFR in two cases, equivalent function in two, and lower function in one. At 36 months, mean eGFR in the treated group was approximately 48 mL/min/1.73 m² versus 40 mL/min/1.73 m² in the untreated paired-kidney group, a 20% difference, though the treated cohort carried a higher mean BMI of 30 versus 25, a confound associated with elevated risk of Delayed Graft Function (DGF).

At 60 months, eGFR converged between the two groups (n=4+4), but the dataset carries a structural asymmetry: the poorest-performing untreated paired kidney required retransplantation at 36 months, removing that patient from the eGFR comparison while the Renaparin®-treated contralateral recipient maintained satisfactory function through month 60. The small cohort size precludes statistical significance, and Corline acknowledges this limitation directly, the signal is hypothesis-generating, not confirmatory.

For drug developers and regulatory affairs teams, the practical read is that STARS-nob fulfils its intended role: long-term safety surveillance post-Phase 1, with paired-kidney methodology providing the most defensible comparator available outside a randomised design. The data now support transition to RENAPAIR 02, a 80-patient randomised study approved to run across sites in England, Germany, and Austria, with primary endpoint eGFR at three months. Key Opinion Leaders have indicated a 10% eGFR improvement would constitute clinical relevance, a threshold that frames the power assumptions underpinning RENAPAIR 02's design.

The 60-month dataset also aligns with preclinical findings previously reported by Corline, adding longitudinal clinical consistency to the mechanistic rationale for heparin-coating in renal preservation. Regulatory submissions for RENAPAIR 02 will need to integrate STARS-nob's safety narrative alongside the Phase 1 conclusions published in September 2022.

Enrolment progress in RENAPAIR 02 across its three approved geographies will be the next measurable indicator of whether the 60-month safety signal translates into a confirmatory efficacy programme.

Source: Corline Biomedical AB via GlobeNewswire, 2 July 2026.