SCO-792 Phase 2a in Subjects with Type 2 Diabetes and Albuminuria.

Phase 2

Completed

• Conditions: Type 2 Diabetes and Albuminuria

• Registration Number: JPRN-jRCT1080225017
• Lead Sponsor: SCOHIA PHARMA, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-16
• Study Completion: 2021-06-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

The subject signs and dates a written, informed consent form prior to the initiation of any study procedures
-The subject is capable of understanding and complying with protocol requirements
-The subject is either male or female and aged 18 to 75 years (inclusive) at signing of informed consent
-The subject has been treated with stable doses of the same RAS inhibitors for at least 3 months prior to Visit 1
-The subject has been treated with stable doses of AHA monotherapy or combination therapy for at least 3 months prior to Visit 1
-The subject has UACR >=200 mg/gCr to <5000 mg/gCr
-The subject has a HbA1c =< 10.5%

Exclusion Criteria

-The subject has a history of type 1 diabetes mellitus
-The subject has a confirmed diagnosis of a renal disease other than type 2 DKD (eg, lupus nephritis, primary focal segmental glomerulosclerosis, acute or chronic glomerular nephritis, bilateral or unilateral renal artery stenosis or polycystic kidney disease). Concomitant hypertensive nephrosclerosis is not prohibited

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>exploratory<br>-Incidence and severity of adverse events (AE)<br>-Incidence of serious adverse events<br>-Clinically significant changes from baseline in<br>-Clinical laboratory tests<br>-12-lead electrocardiograms<br>-vital signs<br>-physical examinations<br>-Incidence and severity of hypoglycemia and hyperglycemia<br>efficacy<br>exploratory<br>Change in log-transformed UACR from baseline at the ompletion of the treatment period (Week 12).

Secondary Outcome Measures

Name	Time	Method
efficacy<br>exploratory<br>Change in eGFR value from baseline at the completion of the treatment period (Week 12).<br>efficacy<br>exploratory<br>Responder rate (UACR decreased by>= 30%) from baseline at the completion of the treatment period (Week 12).