Rilparencel Autologous Cell Therapy in Patients with Diabetes and Advanced CKD: Phase 2 Interim Results
Bibliographic record
Abstract
Background: Cell-based therapies in patients with chronic kidney disease (CKD) may repair diseased nephrons and stabilize kidney function. We describe an interim analysis of an open label phase 2 trial (NCT05018416) with rilparencel, an autologous cell product made from kidney biopsy tissue. Methods: The study objectives are to evaluate efficacy and safety measured by change in eGFR slope from baseline to after last injection and procedure- and product-related serious adverse events. Patients with type 1 or 2 diabetes, eGFR 20-50 ml/min/1.73/m2 and UACR 30-5000 mg/g are randomized into one of two cohorts. Cohort 1 subjects receive two percutaneous rilparencel injections: one into the cortex of each kidney 3 to 5 months apart; Cohort 2 subjects receive at least one injection, and a 2nd injection only after a pre-defined biochemical trigger. eGFR slope is presented for only Cohort 1 given its alignment with an ongoing phase 3 trial. Safety data is aggregated across both cohorts. A post-hoc analysis compares eGFR slope in Cohort 1 with a 10:1 matched synthetic control group. The control group was identified from a subject-level clinical trial database and matched with Cohort 1 based on risk of kidney failure (Klinrisk model). Results: 49 subjects received the 1st injection (n=24 Cohort 1; n=25 Cohort 2) and 34 subjects received a 2nd injection (n=22 Cohort 1; n=12 Cohort 2); 28 subjects have not completed the study and remain in follow up (n=11 Cohort 1; n=17 Cohort 2). 13 Cohort 1 subjects have greater than 12 months follow up post 2nd injection. Mean age is 63 yrs; 54% are female. At baseline, mean (SD) eGFR is 27.9 (9.5) ml/min/1.73/m2; median [IQR] UACR is 239 [4, 2392] mg/g. Annualized eGFR slope in Cohort 1 is -1.1 ml/min/1.73/m2/year (95% CI -3.5, 1.3). Average change in eGFR in the matched control group is -4.0 ml/min/1.73/m2 over 12-months. Two hematomas and 2 episodes of acute kidney injury occurred after kidney biopsy; 1 hematoma occurred after 83 injections. There were no product-related SAEs. Conclusion: Interim findings suggest rilparencel can stabilize kidney function in patients with diabetes and advanced CKD. Procedure-related AEs are infrequent and typical given the interventions. A global phase 3 study is ongoing to determine efficacy and safety of rilparencel. Funding: Commercial Support - ProKidney
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".