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LNP023 for Membranous Glomerulonephritis

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Estimated GFR (using the CKD-EPI formula) ≥ 30 mL/min per 1.73 m2 at screening
Receiving stable dose at the maximum recommended dose according to local guidelines or maximum tolerated dose of ACEi and/or ARB and/or statins and/or diuretics for at least 8 weeks prior to Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29 and day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose)
Awards & highlights

Study Summary

This trial will compare LNP023 to rituximab to see if LNP023 is more effective and safe in treating MN.

Eligible Conditions
  • Membranous Glomerulonephritis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29 and day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 and day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ratio between baseline Urine Protein Creatinine Ratio and Urine Protein Creatinine Ratio at 24 weeks of treatment (from 24h urine collection)
Secondary outcome measures
Change in (eGFR) estimated Glomerular Filtration Rate from baseline to 24 weeks of treatment
Meausrement of Plasma levels of Bb and sC5b-9
Pharmacokinetic parameter AUClast in plasma
+7 more

Side effects data

From 2023 Phase 3 trial • 97 Patients • NCT04558918
20%
COVID-19
17%
Breakthrough haemolysis
9%
Sinusitis
9%
Pyrexia
9%
Blood lactate dehydrogenase increased
9%
Upper respiratory tract infection
6%
Back pain
6%
Diarrhoea
6%
Nasopharyngitis
3%
Nausea
3%
Influenza A virus test positive
3%
Intervertebral discitis
3%
Extravascular haemolysis
3%
Jaundice
3%
Acute kidney injury
3%
Bilirubinuria
3%
Abdominal pain
3%
Arthralgia
3%
Arthritis bacterial
3%
Urinary tract infection
3%
Sepsis
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anti-C5 Antibody (Randomized Treatment Period)
LNP023 200mg b.i.d. (Randomized Treatment Period + Extension Treatment Period)
Any LNP023 200mg b.i.d. (Randomized Treatment Period + Extension Treatment Period)
LNP023 200mg b.i.d. (Randomized Treatment Period)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LNP023Experimental Treatment1 Intervention
LNP023
Group II: RituximabActive Control1 Intervention
Rituximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LNP023
2019
Completed Phase 3
~260

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,197,552 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the approximate number of participants engaged in this research project?

"Affirmative. The clinicaltrials.gov listings indicate that recruitment for this research has started and is ongoing, with the original posting dating back to November 23rd 2019. There are currently 4 sites searching for a total of 52 participants."

Answered by AI

Are there any openings in this medical investigation that would accommodate a new participant?

"Clinicaltrials.gov verifies that this medical experiment is actively engaging participants. It was initially posted on the 23rd of November 2019 and the most recent iteration occurred on 18th of November 2022."

Answered by AI

In which geographical areas is the trial being conducted?

"This clinical trial is presently being conducted in 4 different cities: Cleveland, New york, Temple and more. It would be beneficial to choose the closest medical centre for you to minimize your commuting needs should you participate."

Answered by AI

Could you provide a summary of the research done on LNP023 thus far?

"The initial trials of LNP023 took place in 1993 at the National Institutes of Health Clinical Center, 9000 Rockville Pike. 809 studies have been conducted since then; presently 415 live experiments are taking place across the nation with a significant percentage based out of Cleveland, Ohio."

Answered by AI

What health conditions is LNP023 commonly used to treat?

"LNP023 is an efficacious therapy for the treatment of diffuse large b-cell lymphoma, in addition to conditions such as polyangium and pemphigus vulgaris."

Answered by AI

Has the FDA approved LNP023 for therapeutic use?

"The efficacy of LNP023 is yet to be proven, thus it scored a 2 on our team's safety scale. This Phase 2 trial has yielded some reassuring data regarding the drug's security profile."

Answered by AI
~7 spots leftby Mar 2025