Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy

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

ClinicalTrials.gov Identifier: NCT03804879

Novartis Reference Number: CLMB763X2202

Last Update: Apr 15, 2021

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore has the potential to improve the management of diabetic kidney disease when added to the standard of care (angiotensin converting enzyme inhibitor or angiotensin receptor blocker). This non-confirmatory Phase 2 study is designed to determine the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at a dose level that is standard of care as judged by the study doctor in patients with type 2 diabetes and nephropathy.

Condition 
Diabetic Nephropathy
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
116 participants
Start date 
Dec 17, 2018
Completion date 
May 18, 2022
Gender 
All
Age(s)
18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug
LMB763
LMB763 capsule
Other
Placebo
Placebo capsule

Eligibility Criteria

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 at screening while receiving a dose of angiotensin converting enzyme inhibitor or angiotensin receptor blocker that is the standard of care as judged by the study doctor.

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 basic methods of contraception during dosing of study treatment
Uncontrolled diabetes mellitus at screening
History or current diagnosis of ECG abnormalities prior to first study dose
History of kidney disease other than diabetic nephropathy at screening
Uncontrolled hypertension at screening
Use of prohibited medications, including but not limited to GLP-1 agonists and SGLT2 inhibitors.

Study Locations

United States
Novartis Investigative Site
Recruiting
Newport Beach, 92663
California
United States
Novartis Investigative Site
Recruiting
Miami Lakes, 33014
Florida
United States
Novartis Investigative Site
Recruiting
Winter Park, 32789
Florida
United States
Novartis Investigative Site
Recruiting
Minneapolis, 55455
Minnesota
United States
Novartis Investigative Site
Recruiting
Albany, 12206
New York
United States
Novartis Investigative Site
Recruiting
El Paso, 79935
Texas
United States
Novartis Investigative Site
Recruiting
Laredo, 78041
Texas
United States
Novartis Investigative Site
Recruiting
Sugar Land, 77479
Texas
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, 1407
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Caba, C1056ABJ
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, C1120AAC
-
Argentina
Czech Republic
Novartis Investigative Site
Recruiting
Prague 4, 140 21
-
Czech Republic
Novartis Investigative Site
Recruiting
Praha, 12808
-
Czech Republic
Jordan
Novartis Investigative Site
Recruiting
Amman, 11941
-
Jordan
Lebanon
Novartis Investigative Site
Recruiting
Ashrafieh, 166830
-
Lebanon
Novartis Investigative Site
Recruiting
Ashrafieh,
-
Lebanon
Novartis Investigative Site
Recruiting
Saida, 652
-
Lebanon
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
Recruiting
Kocaeli, 41380
-
Turkey
Novartis Investigative Site
Recruiting
Talas / Kayseri, 38039
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]