drugset / Trial / NCT03990363
A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this clinical research study is to establish the dose of verinurad combined with allopurinol 300 mg once daily that will elicit the desired response; ie, reduction in urinary albumin to creatinine ratio (UACR) at 6 months.
Timeline
- Start
- 2019-07-23
- Primary completion
- 2021-11-22
- Completion
- 2021-11-22
Outcome
Missed primary endpoint
paper Verinurad 3, 7.5, and 12 mg in combination with allopurinol 300 mg did not reduce albuminuria during 34 weeks treatment compared with allopurinol alone or placebo. PMID 38564654 ↗
registry analysis (superiority test); High Dose Versus Placebo; p = 0.0648; Repeated Measures Mixed Model NCT03990363 ↗
Publications
- Heerspink HJL, Stack AG, Terkeltaub R, Jongs N, Inker LA, Bjursell M, Maklad N, Perl S, Eklund O, Rikte T, Sjostrom CD, Perkovic V; SAPPHIRE Investigators. Combination Treatment with Verinurad and Allopurinol in CKD: A Randomized Placebo and Active Controlled Trial. J Am Soc Nephrol. 2024 May 1;35(5):594-606. doi: 10.1681/ASN.0000000000000326. Epub 2024 Feb 20.
- Heerspink HJL, Stack AG, Terkeltaub R, Greene TA, Inker LA, Bjursell M, Perl S, Rikte T, Erlandsson F, Perkovic V. Rationale, design, demographics and baseline characteristics of the randomized, controlled, Phase 2b SAPPHIRE study of verinurad plus allopurinol in patients with chronic kidney disease and hyperuricaemia. Nephrol Dial Transplant. 2022 Jul 26;37(8):1461-1471. doi: 10.1093/ndt/gfab237.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allopurinol | Small molecule | 300 mg | — |
| Subject | Verinurad | Small molecule | 3 mg | — |
| Subject | Verinurad | Small molecule | 7.5 mg | — |
| Subject | Verinurad | Small molecule | 12 mg | — |