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Trial details
Trial details
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
Current status:
Approved
|
Date registered:
02/11/2019
Trial version(s)
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
History: 09/02/2019
Current: 09/02/2019
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Main Information
Primary registry identifying number
LBCTR2019020193
Protocol number
CLMB763X2202
MOH registration number
7936/2019
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public 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
Acronym
Scientific 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
Acronym
Brief summary of the study: English
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.
Brief summary of the study: Arabic
دراسة من 24 أسبوعًا عشوائيّة التوزيع ومزدوجة التعمية من جهة المريض والطبيب ومرتكزة على المقارنة بدواء وهميّ لتقييم سلامة وقدرة تحمّل وفعاليّة دواء LMB763 لدى المرضى المصابين باعتلال الكلية السكّري
Health conditions/problem studied: Specify
Patients with Diabetic Nephropathy
Interventions: Specify
•Drug: LMB763 LMB763 capsule •Other: Placebo Placebo capsule
Key inclusion and exclusion criteria: Inclusion 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 maximally tolerated (optimal) dose of angiotensin converting enzyme inhibitor or angiotensin receptor blocker
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
75
Key inclusion and exclusion criteria: Exclusion criteria
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
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Other
Trial scope: Specify scope
Safety, tolerability and efficacy
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
2
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
LMB763 (Nidufexor)
Type of IMP
Others
Type of IMP: Specify
LMB763 (nidufexor) is a potent partial agonist of the bile acid receptor Farnesoid X Receptor (FXR).
Pharmaceutical class
Nidufexor (LMB763) is a potent partial agonist of the Farnesoid X Receptor (FXR).
Therapeutic indication
Patients with intrahepatic cholestasis and for non-alcoholic steatohepatitis (NASH), and diabetic nephropathy.
Therapeutic benefit
•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
Biospecimen retention
Samples with DNA**
Biospecimen description
All blood samples will be sent to Covance-central laboratories, as per study protocol to assess patient disease response following treatment administration. Primary plasma samples for PK are stored at the bioanalytical lab (Veeda – address below) and are destroyed 6 months after study finalization.
Target sample size
20
Actual enrollment target size
2
Date of first enrollment: Type
Actual
Date of first enrollment: Date
15/05/2019
Date of study closure: Type
Actual
Date of study closure: Date
09/02/2021
Recruitment status
Recruiting
Date of completion
04/02/2020
IPD sharing statement plan
No
IPD sharing statement description
Not provided on clinical trials.gov
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT03804879?term=CLMB763X2202&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinical Trials. gov
NCT03804879
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Hilal
Abu Zeinab
Saida
Lebanon
9613811611
hilal@abouzeinab.com
Hammoud Hospital
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Sola
Aoun
Beirut
Lebanon
961 1 786456 ext. 2336
sola.bahous@lau.edu.lb
UMC Rizk Hospital
Public
Hiba
Azar
Beirut
Lebanon
70 528 328
hibaazar@hotmail.com
Hotel Dieu
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hammoud Hospital University Medical Center
Dr Hilal Abuzeinab
Nephrology
Approved
University Medical Center Rizk Hospital
Dr Sola Aoun
Nephrology
Approved
Hotel Dieu De France
Dr Hiba Azar
Nephrology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hammoud Hospital University Medical Center
29/01/2019
Ahmad Zaatari
zaatari@hammoudhospital.com
+961 (0) 7 723111 ext 1160
Lebanese American University- University Medical Center Rizk Hospital
11/04/2019
Christine Chalhoub
christine.chalhoub@lau.edu.lb
961 9 547254 ext. 2340
Hotel Dieu de France
05/02/2019
Nancy Alam
nancy.alam@usj.edu.lb
+961 (0) 1 421000 ext 2335
Countries of Recruitment
Name
Argentina
Czech Republic
Germany
Jordan
Lebanon
United States of America
Turkey
Health Conditions or Problems Studied
Condition
Code
Keyword
Diabetic nephropathy
Nephropathy induced by unspecified drug, medicament or biological substance (N14.2)
Nephropathy
Interventions
Intervention
Description
Keyword
Reference table 8-1 of the study protocol: Mainly ICF, IMP administration , Lab tests , ECG
ICF, IMP, Lab tests and ECG , diary completion
ICF, IMP, Lab tests and ECG , diary completion
Primary Outcomes
Name
Time points
Measure
To compare the effect of LMB763 to
at serial timepoints as discrived in protoocl
serial timepoints as per protocol
•Adverse event profile and safety endpoints of LMB763
197 days
197 days
Key Secondary Outcomes
Name
Time points
Measure
To determine the effect of LMB763 on
Estimated glomerular filtration rate (eGFR), as
eGFR
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial