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NCT05593575
Efficacy and Safety of SPH3127 Tablets on Treating the Diabetic Kidney Disease
Phase 2 trial testing SPH3127+SPH3127matching placebo+valsartan matching placebo in Diabetic Kidney Disease in 305 participants. Completed in 31 December 2024.
31 December 2024
Quick facts
| Lead sponsor | Shanghai Pharmaceuticals Holding Co., Ltd |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 305 |
| Start date | 22 March 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 45 locations across China |
Drugs / interventions tested
- SPH3127+SPH3127matching placebo+valsartan matching placebo — full drug profile →
- SPH3127+SPH3127matching placebo+valsartan matching placebo — full drug profile →
- SPH3127+valsartan matching placebo — full drug profile →
- SPH3127 matching placebo+valsartan — full drug profile →
Conditions studied
- Diabetic Kidney Disease — all drugs for Diabetic Kidney Disease →
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd — full company profile →
Who can join
Adults 18 to 75, any sex, with Diabetic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To preliminarily evaluate the efficacy and safety of the renin inhibitor (SPH3127 tablets) in reduction in proteinuria in patients with diabetic kidney disease with valsartan as the comparator, and determine the recommended dose.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease.
Natale P, Palmer SC, Navaneethan SD, Craig JC, et al · · 2024 · cited 12× · PMID 38682786 · DOI 10.1002/14651858.cd006257.pub2
Verify or expand the search:
- PubMed search for NCT05593575
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetic Kidney Disease
Currently open trials in the same condition.
- NCT07169422 — Improving Kidney Care in Type 2 Diabetes: A Study of Pharmacist Prescribing Versus Usual Care · NA · recruiting
- NCT06666283 — A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients · Phase 1 · recruiting
- NCT07338435 — "Residual Kidney Function and Oxidative Stress in Incremental vs Standard Peritoneal Dialysis (2 Mexican Centers)" · NA · active not recruiting
- NCT06441591 — Clinical Outcome of Vinpocetine in Diabetic Nephropathy · Phase 2, PHASE3 · recruiting
- NCT06532682 — Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes · Phase 4 · active not recruiting
Other Shanghai Pharmaceuticals Holding Co., Ltd trials
Trials by the same sponsor.
- NCT06839131 — A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects. · Phase 1 · recruiting
- NCT06487455 — A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors. · Phase 1 · recruiting
- NCT06434597 — A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patient · Phase 2 · recruiting
- NCT06483373 — A Clinical Study of SPH7854 Granules in Healthy Subjects. · EARLY_PHASE1 · recruiting
- NCT05046314 — A Clinical Study of TK216 in Patients With Relapsed or Refractory Ewing's Sarcoma · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05593575 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Pharmaceuticals Holding Co., Ltd
- Last refreshed: 19 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05593575.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing