Safety, Tolerability and Efficacy of LMB763 in Patients With Diabetic Nephropathy
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetic Neuropathy, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/28/2019 |
| Start Date: | February 5, 2019 |
| End Date: | July 2, 2021 |
| Contact: | Novartis Pharmaceuticals |
| Email: | novartis.email@novartis.com |
| Phone: | 1-888-669-6682 |
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
LMB763 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 LMB763 in combination with maximally tolerated doses
of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in
patients with type 2 diabetes and nephropathy.
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 LMB763 in combination with maximally tolerated doses
of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in
patients with type 2 diabetes and nephropathy.
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
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