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Safety, Tolerability and Efficacy of LMB763 in Patients With Diabetic Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03804879
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 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 or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: LMB763 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LMB763
LMB763 capsules
Drug: LMB763
LMB763 capsule

Placebo Comparator: Placebo
Placebo comparator
Other: Placebo
Placebo capsule




Primary Outcome Measures :
  1. Change from baseline in urinary albumin to creatinine ratio and 24 hour urinary albumin [ Time Frame: 168 days ]
    Effect of LMB763 to placebo on albuminuria in patients with diabetic nephropathy already receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)

  2. Incidence of treatment emergent adverse events and study drug related adverse events. [ Time Frame: 168 days ]
    Adverse event profile and safety endpoints of LMB763


Secondary Outcome Measures :
  1. Estimated glomerular filtration rate (eGFR) [ Time Frame: 168 days ]
    Effect of LMB763 on renal filtration function utilizing Estimated glomerular filtration rate

  2. Cmax of LMB763 at day 1 and at steady state in patients with type 2 diabetes and nephropathy [ Time Frame: 168 days ]
    To assess the Cmax of LMB763 at day 1 and at steady state in patients with type 2 diabetes and nephropathy

  3. Tmax of LMB763 at day 1 and at steady state in patients with type 2 diabetes and nephropathy [ Time Frame: 168 days ]
    To assess the Tmax of LMB763 at day 1 and at steady state in patients with type 2 diabetes and nephropathy

  4. AUC of LMB763 at day 1 and at steady state in patients with type 2 diabetes and nephropathy [ Time Frame: 168 days ]
    To assess the AUC of LMB763 on day 1 and at steady state in patients with type 2 diabetes and nephropathy

  5. Change from baseline in Free water clearance [ Time Frame: 168 days ]
    Effect of LMB763 on renal tubular function utilizing Free water clearance

  6. Change from baseline in weight, BMI and/or waist-to-hip ratio. [ Time Frame: 168 days ]
    Effect of LMB763 on anthropometric assessments (weight, height, and waist-to-hip ratio)

  7. Change from baseline in the Fasting lipid profile, including lipoprotein (a) [Lp(a)] [ Time Frame: 168 days ]
    Effect of LMB763 on lipids utilizing Fasting lipid profile, including lipoprotein (a) [Lp(a)]



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 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
  • Uncontrolled hypertension
  • Use of prohibited medications, including but not limited to GLP-1 agonists and SGLT2 inhibitors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804879


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, California
Novartis Investigative Site Recruiting
Newport Beach, California, United States, 92663
United States, Florida
Novartis Investigative Site Recruiting
Miami Lakes, Florida, United States, 33014
Novartis Investigative Site Recruiting
Winter Park, Florida, United States, 32789
United States, Minnesota
Novartis Investigative Site Recruiting
Minneapolis, Minnesota, United States, 55455
United States, New York
Novartis Investigative Site Recruiting
Albany, New York, United States, 12206
United States, Oklahoma
Novartis Investigative Site Recruiting
Norman, Oklahoma, United States, 73069
United States, Texas
Novartis Investigative Site Recruiting
El Paso, Texas, United States, 79935
Novartis Investigative Site Recruiting
Laredo, Texas, United States, 78041
Novartis Investigative Site Recruiting
Sugar Land, Texas, United States, 77479
Argentina
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, 1407
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, C1056ABJ
Novartis Investigative Site Recruiting
Buenos Aires, Argentina, C1120AAC
Czechia
Novartis Investigative Site Recruiting
Prague 4, Czechia, 140 21
Novartis Investigative Site Recruiting
Praha, Czechia, 12808
Germany
Novartis Investigative Site Recruiting
Essen, Nordrhine Westphalia, Germany, 45136
Novartis Investigative Site Recruiting
Berlin, Germany, 10787
Novartis Investigative Site Recruiting
Elsterwerda, Germany, 04910
Novartis Investigative Site Withdrawn
Saarlouis, Germany, 66740
Jordan
Novartis Investigative Site Recruiting
Amman, Jordan, 11941
Lebanon
Novartis Investigative Site Recruiting
Ashrafieh, Lebanon
Novartis Investigative Site Recruiting
Saida, Lebanon, 652
Turkey
Novartis Investigative Site Recruiting
Istanbul, TUR, Turkey, 34098
Novartis Investigative Site Recruiting
Kocaeli, Turkey, 41380
Novartis Investigative Site Recruiting
Talas / Kayseri, Turkey, 38039
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03804879    
Other Study ID Numbers: CLMB763X2202
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
diabetes
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases