A study to see how the study drug MT-3995 is taken up by the body in people with Diabetic Nephropathy

• Conditions: Type II Diabetes Mellitus with Nephropathy and Albuminuria; MedDRA version: 17.0Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-002480-98-BG
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation (MTPC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-27
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

-Male and female subjects aged 18 to 75 years who have been diagnosed with Type II diabetes mellitus according to the criteria of the WHO.
-Subjects with a clinical diagnosis of diabetic nephropathy, who have been treated with ACE-I or ARB for a minimum of 12 weeks prior to screening and have been receiving a stable dose for at least 4 weeks prior to screening and remain on a stable dose up to baseline (Day 1 pre-dose).
-Subjects with stable BP at Week -2 (compared with Week -4) and at baseline, Day 1 pre-dose (compared with Week -2). Stable BP is defined as a DBP within ± 10 mmHg from the previous BP measurement. Subjects must also have a DBP <110 mmHg and an SBP <180 mmHg at Week -4, Week -2 and baseline (Day 1 pre-dose).
-Albuminuria (UACR) =50 mg/g and =3500 mg/g (i.e., =5.66 mg/mmol and =395.85 mg/mmol) measured by median values of first-morning void urine samples on three consecutive days, both at screening and Week -2.
-An estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD] formula) =60 mL/min/1.73m2 at screening and Week -2.Due to variability, subjects with an eGFR of 57-59
mL/min/1.73m2 may be enrolled in the study at the discretion of the
Investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

-Central laboratory serum potassium level <3.5 or >5.2 mmol/L at screening, Week -2 or baseline (Day 1 pre-dose).
-Local laboratory serum potassium level <3.5 or >5.2 mmol/L at baseline (Day 1 pre-dose).
-Clinically significant abnormalities of the thyroid (hypo- or hyperthyroidism measured by thyroid stimulating hormone, free triiodothyronine and free thyroxine) at screening or Week -2, or subjects on thyroxine replacement therapy.
-Subjects who are on both ARB and ACE-I.
-History of hospitalisation for hyperkalemia or acute kidney injury induced by previous renin-angiotensin-aldosterone system blocker treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified