A randomized patient-and-physician blinded, placebo- controlled, 24-week study to assess the safety, tolerability and efficacy of LMB763 in patients with diabetic nephropathy
- Conditions
- Patients with Diabetic NephropathyNephropathyN14.2
- Registration Number
- LBCTR2019020193
- Lead Sponsor
- ovartis Pharma Services Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 5
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
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 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: To compare the effect of LMB763 to;Timepoints: at serial timepoints as discrived in protoocl ;Measure: serial timepoints as per protocol;Name: •Adverse event profile and safety endpoints of LMB763 ;Timepoints: 197 days;Measure: 197 days
- Secondary Outcome Measures
Name Time Method ame: To determine the effect of LMB763 on;Timepoints: Estimated glomerular filtration rate (eGFR), as;Measure: eGFR