A Study of CS-3150 to Evaluate Safety in Japanese Type 2 Diabetic Patients with Macroalbuminuria
- Conditions
- Type 2 diabetic patients with macroalbuminuria
- Registration Number
- JPRN-jRCT2080223640
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
When CS-3150 was administered to patients with type 2 diabetes and macroalbuminuria taking an ARB or ACE inhibitor for 28 weeks, UACR continued to decrease until the end of treatment, and the proportion of patients with improvement from overt nephropathy to early nephropathy continued to increase until the end of treatment. As for SAEs, none of the events were considered related to study drug. CS-3150 treatment was well-tolerated when initiated at a low dosage and titrated upwards over time.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 56
1) Patients aged 20 years or older at the time obtaining informed consent
2) Patients diagnosed to have type 2 diabetes mellitus
3) Patients who meet any of the following in the laboratory tests (central measurement) at run in period.
i.Patients with UACR >= 300 mg/g creatinine and < 1000 mg/g creatinine in the early morning first urine at least twice.
ii. Patients with eGFRcreat >= 30 mL/min/1.73 m2
4) Hypertensive patients who have been taking an ARB or an ACE inhibitor for at least 12 weeks prior to the study drug administration without changing the dosage and administration.
1) Patients with type 1 diabetes mellitus
2) Patients with secondary glucose tolerance impairment
3) Patients diagnosed to have non-diabetic nephropathy
4) Patients with secondary hypertension
5) Patients who were hospitalized for hyperkalemia within 1 year before informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>1. Proportion of each adverse event<br>2. Change in clinical laboratory parameters, vital sign <br>3. Time course of changes in UACR, eGFR, and blood pressure <br>4. Inprovement rate from macroalbuminuria to microalbuminuria
- Secondary Outcome Measures
Name Time Method