Diabetic NephropathyPhase 2UPWARDNCT02327754
Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout
A Phase 2 study testing Topiroxostat BID, (Oral daily dosing for 28 weeks) in people with Diabetic Nephropathy, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Topiroxostat BID, (Oral daily dosing for 28 weeks)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Start not givento Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient has known non-diabetic nephropathy (other than nephrosclerosis)
Trial locations and contacts
1 site in 1 country.
About this study
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).
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.
- Conditions
- Diabetic Nephropathy
- Being tested
- Topiroxostat BID, (Oral daily dosing for 28 weeks), Placebo BID, (Oral daily dosing for 28 weeks)
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active comparator | Active comparator | Topiroxostat, (Oral daily dosing for 28 weeks) Receives: Drug: Topiroxostat BID, (Oral daily dosing for 28 weeks) |
| Placebo comparator | Placebo comparator | Placebo, (Oral daily dosing for 28 weeks) Receives: Drug: Placebo BID, (Oral daily dosing for 28 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in urine albumin creatinine ratio
Measured: 28 weeks
Secondary outcomes (1)
sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fuji Yakuhin Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327754
- Sponsor's protocol ID
- FY1004
- Acronym
- UPWARD
- Status last verified
- Nov 2015
- First submitted
- 24 Dec 2014
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT02327754
- Acronym / sponsor ID
- UPWARD / FY1004
- Conditions
- Diabetic Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fuji Yakuhin Co., Ltd.
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active comparator | Active comparator | Drug: Topiroxostat BID, (Oral daily dosing for 28 weeks)Topiroxostat, (Oral daily dosing for 28 weeks) |
| Placebo comparator | Placebo comparator | Drug: Placebo BID, (Oral daily dosing for 28 weeks)Placebo, (Oral daily dosing for 28 weeks) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patient has known non-diabetic nephropathy (other than nephrosclerosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiroxostat BID, (Oral daily dosing for 28 weeks)The dose of topiroxostat is increased up to 160 mg/day in a stepwise manner. | Drug | Active comparator |
| Placebo BID, (Oral daily dosing for 28 weeks)Subjects randomized to the placebo arm will receive placebo. | Drug | Placebo comparator |
Primary outcome
Change from baseline in urine albumin creatinine ratio
Time frame: 28 weeks
1 secondary outcome
sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topiroxostat BID, (Oral daily dosing for 28 weeks) in people with Diabetic Nephropathy, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in urine albumin creatinine ratio (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.