A randomized, treatment open-label, dose-blinded parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy

Overview Specialty Published Date Contact Details Study Description

Principal Investigator

Clin Assoc Prof Jason Choo

Senior Consultant

Singapore General Hospital

Renal Medicine

Organised By

Renal Medicine

Overview

Intervention

LNP023 is an oral medication that inhibits Factor B (a key component of the alternative complement pathway) which may improve MN.
Rituximab belongs to a class of drugs called monoclonal antibodies. It binds to a protein called CD20 found on the surface of B-cells; B-cells are a group of white blood cells, which are part of the body's defense system, and play a role in MN. This medicine is given as Infusion.

Eligibility Criteria

Age ≥ 21 years old.
Diagnosis of Idiopathic Membranous Nephropathy.
Weight >35 kg.
On maximal tolerated stable dose of ACEi and/or ARB therapy or statins or diuretics. (E.g. Enalapril, Losartan, Simvastatin, Furosemide).

Involvement

Participate study for about 65 weeks (1 year and 3 months) and visit the Study Doctor about 14 times. Collect health information from you. Collect your blood and urine samples. Perform ECG (Measure electrical activity of your heart) on you.
Record your vital signs (body temp, blood pressure and pulse).
Complete questionnaires.
Perform Physical Examination on you.
Receive vaccinations (if required).

Eligible Volunteers will receive

Allocated treatment (2/3 of chance to get LNP023 oral drug and 1/3 of chance to get Rituximab infusion).
Transport reimbursement on each visit.
Study-related activities are covered (e.g., randomized treatment, consultation fee, lab tests, vaccinations).

Specialty

Renal Medicine

Published Date

12/10/2020

Contact Details

Clinical Trials and Research Centre, Singapore General Hospital
Email: grcctrc1@sgh.com.sg (Quote 'Novartis CLNP023D12201')

Study Description

The purpose of the study is to find out if the drug called “LNP023” is safe and has beneficial effects in people who have membranous nephropathy (MN) compared with rituximab.

MN is a disease of the kidney that causes an increase in the amount of protein eliminated in the urine.

The main objective of this research is to see whether taking LNP023 or rituximab for 6 months results in lower urine protein levels and to compare these two treatments in patients with MN.

Last Updated: 12 October 2020