drugset / Trial / NCT05521191
A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
RandomizedSequentialDouble-blindTreatment
Summary
Primary Objectives * To assess the safety and tolerability of RGLS8429 * To assess the impact of RGLS8429 on ADPKD biomarkers Secondary Objectives * To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) * To characterize the pharmacokinetic (PK) properties of RGLS8429 * To assess the impact of RGLS8429 on renal function
Timeline
- Start
- 2022-10-06
- Primary completion
- 2025-01-27
- Completion
- 2025-03-27
Publications
- Joy MS, Gbadegesin RA, Conway PT, Chertow GM, Liu KD, Lim MD, Kretzler M, Bonventre JV; Precision Medicine Workshop Speakers and Moderators. National Institutes of Health Workshop to Accelerate Therapeutic Innovation by Optimizing Kidney Precision Medicine Clinical Trials. Clin J Am Soc Nephrol. 2026 Feb 17. doi: 10.2215/CJN.0000001031. Online ahead of print.
- St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
- Tekendo-Ngongang C, Gleeson JG, Mignon L. Treating the Untreatable: Antisense Oligonucleotides as an Individualized Therapy for Rare Genetic Kidney Diseases. J Am Soc Nephrol. 2024 Dec 1;35(12):1774-1777. doi: 10.1681/ASN.0000000532. Epub 2024 Sep 27. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RGLS8429 | Unknown | 300 mg | Subcutaneous |