Safety, tolerability and efficacy of LMB763 in patients with diabetic nephropathy

Phase 1

• Conditions: Diabetic Nephropathy; MedDRA version: 21.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-002491-40-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-14
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Male/female patients, 18-75 years
• Written informed consent
• Diagnosis of Type 2 diabetes mellitus, with
diagnosis made at least 6 months prior to screening
• Diabetic nephropathy as evidenced by Urine
albumin-Cr ratio (UACR) =300 mg/g Cr while
receiving a maximally tolerated (optimal) dose of
angiotensin converting enzyme inhibitor or
angiotensin receptor blocker
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 99
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

• History of type 1 diabetes mellitus
• Severe renal impairment manifesting as serum creatinine eGFR < 30 mL/min/1.73 m^2 at screening
• Pregnant or nursing (lactating) women
• Women of child-bearing potential, unless allowed by local regulations and they are using highly effective methods of contraception during dosing and for 5 days after stopping study medication
• Uncontrolled diabetes mellitus
• History or current diagnosis of ECG abnormalities
• History of kidney disease other than diabetic nephropathy

Study & Design

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