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Diabetic NephropathyPhase 2NCT02345057

A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria

A Phase 2 study testing CS-3150 in people with Diabetic Nephropathy, run by Daiichi Sankyo at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese Type 2 Diabetes Mellitus and Microalbuminuria. The Primary endpoint is the change from baseline in urinary albumin to creatine ratio (UACR). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Diabetic Nephropathy
What is being tested?
CS-3150
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
365 participants
Where
1 siteJapan
Study dates
Jan 2015to Jul 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with type 2 diabetes mellitus
  • Male or female subjects aged 20 years or older at informed consent
  • Subjects with urinary albumin to creatine ratio (UACR) ≥ 45 mg/g Cr and < 300 mg/g Cr
  • Estimated glomerular filtration rate by creatinine (eGFRcreat) ≥ 30 mL/min/1.73 m^2
  • Subjects treated with angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 3 months prior to treatment period

Who cannot join

  • Type 1 diabetes
  • HbA1c (NGSP) >=8.4%
  • Secondary glucose intolerance
  • Subjects diagnosed with non-diabetic nephropathy
  • Nephrotic syndrome
  • Secondary hypertension or malignant hypertension
  • Serum potassium level in any of the following categories: For subjects with eGFRcreat of ≥ 45 mL/min/1.73 m^2, serum potassium level of < 3.5 mEq/L or ≥ 5.1 mEq/L; For subjects with eGFRcreat of ≥ 30 mL/min/1.73 m^2 and < 45 mL/min/1.73 m^2, serum potassium level of < 3.5 mEq/L or ≥ 4.8 mEq/L

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Kumamoto, 862-0976

Other trials in Japan

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Type 2 Diabetes Mellitus and Microalbuminuria

This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese Type 2 Diabetes Mellitus and Microalbuminuria.

The Primary endpoint is the change from baseline in urinary albumin to creatine ratio (UACR).

Being tested
CS-3150, placebo
Keywords
Diabetic Nephropathy, mineralocorticoid receptor antagonist, CS-3150, Japanese
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CS-3150Drug

  • placeboDrug

Study groups in NCT02345057
Study groupRoleWhat they receive
CS-3150 0.625 mgExperimentalOne CS-3150 0.625 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
Receives: Drug: CS-3150; Drug: placebo
CS-3150 1.25 mgExperimentalTwo CS-3150 0.625 mg tablets administered orally, once daily after breakfast.
Receives: Drug: CS-3150
CS-3150 2.5 mgExperimentalOne CS-3150 2.5 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
Receives: Drug: CS-3150; Drug: placebo
CS-3150 5.0 mgExperimentalTwo CS-3150 2.5 mg tablets administered orally, once daily after breakfast
Receives: Drug: CS-3150
PlaceboPlacebo comparatorTwo placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in urinary albumin to creatine ratio (UACR)

    Measured: Baseline to end of Week 12

Secondary outcomes (3)

  1. Transition from microalbuminuria to normoalbuminuria

    Measured: Baseline to end of Week 12

  2. Change in renal function

    Measured: Baseline to end of Week 12

  3. Change in serum potassium

    Measured: Baseline to end of Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2016
  4. Study completionJul 2016

Resources

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
365 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02345057
Sponsor's protocol ID
CS3150-B-J204
Status last verified
Sep 2016
First submitted
19 Jan 2015
Last updated
21 Dec 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

    PubMed 33107592

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CS-3150 in people with Diabetic Nephropathy, run by Daiichi Sankyo 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 5 inclusion and 7 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 21 Dec 2018. 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 urinary albumin to creatine ratio (UACR) (time frame: Baseline to end of Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02345057, which also lists 1 linked publication.

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 21 Dec 2018.

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