Who is sponsoring NCT02327754?

NCT02327754 is sponsored by Sanwa Kagaku Kenkyusho Co., Ltd..

What drugs are being tested in NCT02327754?

Interventions in NCT02327754: Topiroxostat BID, (Oral daily dosing for 28 weeks), Placebo BID, (Oral daily dosing for 28 weeks).

What condition does NCT02327754 study?

NCT02327754 studies Diabetic Nephropathy.

Is NCT02327754 still recruiting?

NCT02327754 is currently completed. Last updated 10 April 2017.

Last reviewed 2017-04-10 · How we verify

NCT02327754: UPWARD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Topiroxostat on Urinary Albumin Excretion in Patients With eARly Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout: a Randomized, Placebo-controlled, Double-blind Phase 2a Trial (UPWARD).

Completed Phase 2 Last updated 10 April 2017

What this trial tests

Phase 2 trial testing Topiroxostat BID, (Oral daily dosing for 28 weeks) in Diabetic Nephropathy in 60 participants. Completed in 1 December 2016.

Timeline

Primary endpoint
1 December 2016

1 December 2016

Quick facts

Lead sponsor	Sanwa Kagaku Kenkyusho Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Primary completion	1 December 2016
Estimated completion	1 December 2016
Sites	1 location across Japan

Drugs / interventions tested

Topiroxostat BID, (Oral daily dosing for 28 weeks) — full drug profile →
Placebo BID, (Oral daily dosing for 28 weeks) — full drug profile →

Conditions studied

Diabetic Nephropathy — all drugs for Diabetic Nephropathy →

Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd. — full company profile →

Who can join

Adults 20 to 75, any sex, with Diabetic Nephropathy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change from baseline in urine albumin creatinine ratio
Time frame: 28 weeks

Sponsor's own description

The purpose of this study is to investigate the effect of topiroxostat on urinary albumin excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia with or without gout. Participants are randomized to placebo (n=20) or topiroxostat (n=40) for 28 weeks. The investigational drugs for this study are supplied by FUJI YAKUHIN CO., LTD.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Sources of Vascular Nitric Oxide and Reactive Oxygen Species and Their Regulation
Tejero J, Shiva S, Gladwin MT. · · 2019 · cited 357× · PMID 30379623 · DOI 10.1152/physrev.00036.2017
Horizon 2020 in Diabetic Kidney Disease: The Clinical Trial Pipeline for Add-On Therapies on Top of Renin Angiotensin System Blockade.
Perez-Gomez MV, Sanchez-Niño MD, Sanz AB, Martín-Cleary C, et al · · 2015 · cited 51× · PMID 26239562 · DOI 10.3390/jcm4061325

Verify or expand the search:

Other recruiting trials for Diabetic Nephropathy

Currently open trials in the same condition.

NCT06661174 — A Cohort Study on the Efficacy of Bariatric Surgery for Rapidly Progressing Diabetic Nephropathy · recruiting
NCT00342927 — Family Investigation of Nephropathy and Diabetes (F.I.N.D.) · recruiting

Other Sanwa Kagaku Kenkyusho Co., Ltd. trials

Trials by the same sponsor.

NCT03801980 — Phase 3 Study of SK-1403 · Phase 3 · completed
NCT03626948 — SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis · Phase 3 · completed
NCT03218501 — A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus · Phase 2 · completed
NCT03226171 — Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism · Phase 2 · completed
NCT03116191 — Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02327754 (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 Sanwa Kagaku Kenkyusho Co., Ltd.
Last refreshed: 10 April 2017

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/NCT02327754.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing