Status:
COMPLETED
Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 (So...
Detailed Description
This was a non-confirmatory, multicenter, patient- and investigator-blinded, randomized, and placebo-controlled, proof-of concept trial assessing nidufexor vs. placebo in patients receiving standard o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2021
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT03804879
Start Date
December 17 2018
End Date
May 3 2021
Last Update
August 10 2022
Active Locations (18)
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1
Novartis Investigative Site
Miami Lakes, Florida, United States, 33014
2
Novartis Investigative Site
Albany, New York, United States, 12206
3
Novartis Investigative Site
Norman, Oklahoma, United States, 73069
4
Novartis Investigative Site
El Paso, Texas, United States, 79935