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

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Topiroxostat BID, (Oral daily dosing for 28 weeks)
Placebo BID, (Oral daily dosing for 28 weeks)
Sponsored by
Sanwa Kagaku Kenkyusho Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sanwa Kagaku Kenkyusho Co., Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active comparator

Placebo comparator

Arm Description

Topiroxostat, (Oral daily dosing for 28 weeks)

Placebo, (Oral daily dosing for 28 weeks)

Outcomes

Primary Outcome Measures

Change from baseline in urine albumin creatinine ratio

Secondary Outcome Measures

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

Full Information

First Posted
December 24, 2014
Last Updated
April 10, 2017
Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
Collaborators
Fuji Yakuhin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02327754
Brief Title
Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout
Acronym
UPWARD
Official 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).
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
Collaborators
Fuji Yakuhin Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active comparator
Arm Type
Active Comparator
Arm Description
Topiroxostat, (Oral daily dosing for 28 weeks)
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Arm Description
Placebo, (Oral daily dosing for 28 weeks)
Intervention Type
Drug
Intervention Name(s)
Topiroxostat BID, (Oral daily dosing for 28 weeks)
Intervention Description
The dose of topiroxostat is increased up to 160 mg/day in a stepwise manner.
Intervention Type
Drug
Intervention Name(s)
Placebo BID, (Oral daily dosing for 28 weeks)
Intervention Description
Subjects randomized to the placebo arm will receive placebo.
Primary Outcome Measure Information:
Title
Change from baseline in urine albumin creatinine ratio
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC
Time Frame
28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Sanwa Kagaku Kenkyusho Co., Ltd.
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
461-8631
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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