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NCT05753696
Azilsartan in Patients With Diabetic Kidney Disease and Hypertension
NA trial testing Azilsartan in Proteinuria in 106 participants. Status unknown.
30 October 2024
Quick facts
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 106 |
| Start date | 1 April 2023 |
| Primary completion | 30 October 2024 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Azilsartan — full drug profile →
- Losartan (losartan) — full drug profile →
Conditions studied
- Proteinuria — all drugs for Proteinuria →
- Kidney Dysfunction — all drugs for Kidney Dysfunction →
- Blood Pressure — all drugs for Blood Pressure →
- Diabetic Kidney Disease — all drugs for Diabetic Kidney Disease →
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Who can join
Adults 30 to 70, any sex, with Proteinuria or Kidney Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hypertension is the most common complication in patients with diabetes nephropathy. Strengthening blood pressure and blood sugar control is the basic treatment for patients with diabetes nephropathy. Angiotensin receptor blocker (ARB) and angiotensin-converting enzyme inhibitor (ACEI) are the first line drugs recommended in domestic and international guidelines for diabetes patients to control hypertension. As a new ARB drug, azilsartan has been found to have better antihypertensive effect than other ARB drugs. However, due to the limited sample size and study time, azilsartan has no significant advantage over other ARB drugs in terms of renal protection effect, and has not been systematically studied in diabetes nephropathy population. This study is intended to evaluate the effect of azilsartan on proteinuria and blood pressure improvement in patients with diabetes nephropathy and hypertension through clinical randomized controlled study, so as to accumulate evidence-based evidence of azilsartan in the comprehensive management of heart and kidney protection in this group of people, and promote the development of comprehensive treatment for patients with metabolic disease and renal injury combined with hypertension. This study will compare the advantages and disadvantages of azilsartan and classical ARB drug losartan potassium in terms of proteinuria, blood pressure control and renal function protection in patients with diabetes nephropathy and hypertension; We propose that the main indicator is the change of urinary albumin/creatinine ratio relative to the baseline, and the secondary indicator is the change of 24-hour urinary protein relative to the baseline; Change of blood pressure relative to baseline; Renal function, electrolyte and blood glucose.
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 NCT05753696
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Azilsartan
Trials testing the same drug.
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- NCT02791438 — A Phase 3 Long-term Study of TAK-536 in Pediatric Patients 6 to Less Than 16 Years With Hypertension · Phase 3 · completed
- NCT02100319 — Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes " · completed
- NCT02092025 — Azilsartan Tablets Special Drug Use Surveillance: Long-term Use · completed
Other recruiting trials for Proteinuria
Currently open trials in the same condition.
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- NCT05457283 — A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor · Phase 3 · recruiting
- NCT05196035 — A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, a · Phase 3 · recruiting
Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials
Trials by the same sponsor.
- NCT07445152 — Research on Construction and Verification of Multimodal Medical Imaging Large Model · not yet recruiting
- NCT06775665 — A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population · not yet recruiting
- NCT07533422 — Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing · NA · not yet recruiting
- NCT07487285 — A Non-inferiority Study of Laser Combined With Ultrasonic Debridement Therapy (LCUDT) Versus Manual Combined With Ultras · NA · not yet recruiting
- NCT07505186 — Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma · Phase 2 · not yet recruiting
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 NCT05753696 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Second Affiliated Hospital, School of Medicine, Zhejiang University
- Last refreshed: 3 March 2023
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