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LNP023 for Immunoglobulin A Nephropathy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novartis Investigative Site, Iowa City, IAImmunoglobulin A NephropathyLNP023 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether LNP023 is better than placebo at reducing proteinuria and slowing renal disease progression in people with primary IgA nephropathy.

Eligible Conditions
  • Immunoglobulin A Nephropathy

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
BION-1301 Multiple Doses
2
iptacopan
2
Pegcetacoplan

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 24 months

Baseline and 12 months
Annualized total Estimated Glomerular Filtration Rate slope estimated over 12 months
Baseline and 24 months
Annualized total estimated Glomerular Filtration Rate (eGFR) slope over 24 months).
Baseline and 9 months
Change from baseline in estimated glomerular filtration rate at 9 months
Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire
Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.
Proportion of participants reaching Urine Protein To Creatinine Ratio <1g/g without receiving Corticosteroids/Immunosuppressant or other newly approved drugs or initiating new background therapy for treatment of IgAN or Kidney Replacement Therapy (KRT)
Adrenal Cortex Hormones
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 9 months
Ratio to baseline in Urine Protein-To-Creatinine Ratio (sampled from 24h urine collection) at 9 months
Up to 24 months
Time from randomization to first occurrence of composite kidney failure endpoint event

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
BION-1301 Multiple Doses
3
iptacopan
3
Pegcetacoplan

Side Effects for

LNP023 10mg Follow-up
5%Diarrhoea
5%Asthenia
5%Dizziness
5%Tooth disorder
5%Acute kidney injury
5%Upper respiratory tract infection
5%IgA nephropathy
5%Back pain
5%Influenza
5%Neck pain
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03373461) in the LNP023 10mg Follow-up ARM group. Side effects include: Diarrhoea with 5%, Asthenia with 5%, Dizziness with 5%, Tooth disorder with 5%, Acute kidney injury with 5%.

Trial Design

2 Treatment Groups

LNP023 200mg b.i.d
1 of 2
Placebo to LNP023 200mg b.i.d
1 of 2

Experimental Treatment

Non-Treatment Group

450 Total Participants · 2 Treatment Groups

Primary Treatment: LNP023 · Has Placebo Group · Phase 3

LNP023 200mg b.i.d
Drug
Experimental Group · 1 Intervention: LNP023 · Intervention Types: Drug
Placebo to LNP023 200mg b.i.d
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iptacopan
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,735 Previous Clinical Trials
3,543,593 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Alberta100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Novartis Investigative Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
References

Frequently Asked Questions

What is the ideal sample size for this research?

"That is accurate. The clinical trial was originally advertised on January 25th, 2021 and was last updated on November 7th, 2022. The study is hoping to enroll 450 patients from 42 different sites." - Anonymous Online Contributor

Unverified Answer

Are there any observed side effects of LNP023?

"LNP023 has been given a safety score of 3 by our team at Power. This is because LNP023 is in Phase 3 trials, meaning that there is both efficacy data and multiple rounds of safety data available." - Anonymous Online Contributor

Unverified Answer

Are there different hospitals conducting this research in Canada?

"This research is currently being conducted at 42 different locations, which include El Paso, Rochester, and Marshfield. To minimize potential participant burden, it is recommended to choose a location nearest to you." - Anonymous Online Contributor

Unverified Answer

Are there any other instances where LNP023 has been tested in a clinical setting?

"LNP023 was first studied in 2019 at Novartis Investigative Site. Since then, there have been 18270 completed clinical trials. There are 10 active studies as of now, with a few of these trials taking place in El Paso, Texas." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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