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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Nephropathy

In brief

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 (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)). This non-confirmatory Phase 2 study was designed to determine the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with ACEI or ARB at a dose level that is SoC as judged by the study doctor in patients with type 2 diabetes and nephropathy.

Key facts

Study ID

NCT03804879

Run by

Novartis Pharmaceuticals

People needed

83

Starts

2018-12-17

Expected to finish

2021-05-03

Last updated by the study team

2022-08-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Miami Lakes, Florida, United States
• Novartis Investigative Site — Albany, New York, United States
• Novartis Investigative Site — Norman, Oklahoma, United States
• Novartis Investigative Site — El Paso, Texas, United States
• Novartis Investigative Site — Sugar Land, Texas, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Prague, Czechia
• Novartis Investigative Site — Essen, Nordrhine Westphalia, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Elsterwerda, Germany
• Novartis Investigative Site — Amman, Jordan
• Novartis Investigative Site — El Achrafiyé, Lebanon
• Novartis Investigative Site — Saida, Lebanon
• Novartis Investigative Site — Istanbul, TUR, Turkey (Türkiye)
• Novartis Investigative Site — Kocaeli, Turkey (Türkiye)
• Novartis Investigative Site — Talas / Kayseri, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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