Overview

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

Status:
Completed
Trial end date:
2021-05-03
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
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.