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Completed

NCT Number: NCT02327754

Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout

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.

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanwa Kagaku Kenkyusho Co., Ltd.

Nagoya, Aichi-ken, 461-8631, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes patients
  • Clinically or pathologically diagnosed diabetic nephropathy
  • Hyperuricemic or gout patients
  • Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73m^2 and urine albumin creatinine ratio (UACR) greater than or equal to 45 and less than 300 mg/g

Exclusion criteria

  • Patient has known non-diabetic nephropathy (other than nephrosclerosis)

Treatment and study plan

Topiroxostat BID, (Oral daily dosing for 28 weeks)

Drug

The dose of topiroxostat is increased up to 160 mg/day in a stepwise manner.

Placebo BID, (Oral daily dosing for 28 weeks)

Drug

Subjects randomized to the placebo arm will receive placebo.

Primary outcomes

  1. Change from baseline in urine albumin creatinine ratio

    Time frame: 28 weeks

Secondary outcomes

  1. sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC

    Time frame: 28 weeks

Sponsors and collaborators

Lead sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Industry

Collaborators

  • Fuji Yakuhin Co., Ltd.

Registry information

Official study title

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).

Acronym: UPWARD

Important dates

Primary completion
2016
Study completion
2016
First posted
Dec 30, 2014
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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