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Glomerulonephritis membranoproliferative – Trials in Disease

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Ongoing Clinical Trials for Membranoproliferative Glomerulonephritis

There are currently 3 clinical trials investigating treatments for membranoproliferative glomerulonephritis. These studies are testing medications called iptacopan and pegcetacoplan across multiple European countries, aiming to reduce protein in the urine and improve kidney function for patients with this rare kidney disease.

Clinical trial locations

Study on the Effects of Iptacopan in Patients with Idiopathic Membranoproliferative Glomerulonephritis (IC-MPGN)

This study is testing a medication called iptacopan in patients with a specific type of kidney disease known as idiopathic immune complex mediated membranoproliferative glomerulonephritis. The condition causes inflammation in the kidney’s filtering units, leading to protein leakage into the urine and reduced kidney function.

Main inclusion criteria: Participants must be between 12 and 60 years old with a confirmed diagnosis through kidney biopsy. They should have been taking standard medications like ACE inhibitors or ARBs at stable doses for at least 90 days. Protein levels in urine must be greater than 1.0 g/g, and kidney function must be above a certain threshold. All participants need to be vaccinated against specific infections including meningitis and pneumonia before starting treatment.

Main exclusion criteria: Patients with other types of kidney disease, those outside the age range, pregnant or breastfeeding women, and those with severe allergic reactions to the study medication cannot participate. People currently in other clinical trials or with certain medical conditions that could interfere with the study are also excluded.

Study focus: The trial aims to determine whether iptacopan can reduce protein levels in the urine after six months of treatment. Participants will be randomly assigned to receive either iptacopan or a placebo in a double-blind design. The study will monitor kidney function through blood tests and measure changes in protein levels. Additional assessments include evaluating fatigue levels and tracking any side effects. For adolescent participants, special attention will be given to cardiovascular health monitoring.

Investigational drug: Iptacopan is taken orally as hard gelatin capsules. It works by inhibiting a specific protein in the immune system, which helps reduce inflammation and damage in the kidneys. It is classified as a complement inhibitor.

Study on Long-term Safety and Efficacy of Pegcetacoplan for Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

This is a long-term follow-up study examining pegcetacoplan for patients with two related kidney conditions: C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis. Both conditions involve problems with the immune system that damage the kidneys over time.

Main inclusion criteria: Participants must have completed a previous study called APL2-C3G-310 through the 52-week visit and experienced clinical benefit from pegcetacoplan during that trial. They need to remain on stable treatment for their condition and maintain current vaccinations against specific bacterial infections. Women of childbearing potential must use effective contraception and have negative pregnancy tests. Participants must be able to self-administer the medication or have a caregiver who can assist.

Main exclusion criteria: Those with severe allergic reactions to the study medication, active infections requiring treatment, pregnant or breastfeeding women, and patients with kidney transplants are excluded. People with drug or alcohol abuse history within the past year or any medical condition deemed unsafe by study doctors cannot participate. Those who have recently received certain immune-suppressing medications are also excluded.

Study focus: The trial monitors the long-term safety and effectiveness of pegcetacoplan over several years, with the study expected to continue until July 2027. Regular follow-up visits include blood and urine tests to measure kidney function and protein levels. The study evaluates whether the medication maintains its benefits over time and monitors for any side effects that may emerge with extended use.

Investigational drug: Pegcetacoplan is administered as an injection under the skin. It works by targeting the complement system, a part of the immune system that is often overactive in these kidney diseases. By controlling this system, the medication aims to reduce kidney damage and improve function.

Study on the Effectiveness and Safety of Pegcetacoplan for Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

This study evaluates pegcetacoplan in patients with C3 glomerulopathy or immune complex membranoproliferative glomerulonephritis. These are rare conditions where abnormal immune system activity leads to inflammation and damage in the kidney’s filtering units.

Main inclusion criteria: Adults aged 18 and older, or adolescents aged 12-17 weighing at least 30 kg, can participate. Patients must have a confirmed diagnosis of primary C3G or IC-MPGN through kidney biopsy or other specific tests, with active signs of kidney disease. Protein levels in urine must exceed certain thresholds measured through 24-hour urine collection. Kidney function must meet minimum requirements based on estimated glomerular filtration rate. Participants need to be on stable treatment for at least 12 weeks and have received specific vaccinations. Women of childbearing potential must use reliable contraception.

Main exclusion criteria: Patients with other kidney diseases unrelated to C3G or IC-MPGN, those outside the age range, and people unable to follow study procedures are excluded. Pregnant or breastfeeding women, those with severe allergies to the medication, and participants in other clinical trials cannot join. Those with serious medical conditions, kidney transplants, or active infections requiring treatment are also excluded.

Study focus: The trial examines whether pegcetacoplan can reduce protein levels in the urine and improve kidney function over a 26-week treatment period. Participants receive the medication as a subcutaneous injection twice weekly at a dose of 1,080 mg. The study uses a double-blind design where neither participants nor researchers know who receives the actual medication or placebo. Regular monitoring includes blood tests, urine tests, and possibly kidney biopsies to assess changes in kidney health.

Investigational drug: Pegcetacoplan is given as an injection under the skin twice per week. It works by inhibiting the complement pathway, specifically targeting the C3 protein that plays a role in inflammation and tissue damage in these kidney conditions.

Summary

All three clinical trials focus on rare kidney diseases involving immune system dysfunction. Two trials are testing pegcetacoplan while one is evaluating iptacopan, both of which are complement inhibitors that target overactive immune responses damaging the kidneys.

The studies are concentrated in several European countries, with Germany, Italy, and the Netherlands participating in all three trials. France, Czechia, and Spain are involved in two trials each, while Austria, Belgium, Greece, Poland, and Slovakia host one trial each. This broad geographic distribution suggests strong European research collaboration in studying these rare conditions.

A common thread across all trials is the requirement for participants to be vaccinated against specific bacterial infections before starting treatment, reflecting the importance of protecting patients whose immune systems will be affected by the investigational drugs. The studies emphasize careful monitoring of kidney function through regular urine and blood tests, with protein levels in urine serving as a key measure of treatment success.

Ongoing Clinical Trials on Glomerulonephritis membranoproliferative

  • Study on the Effects of Iptacopan in Patients with Idiopathic Membranoproliferative Glomerulonephritis (IC-MPGN)

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Germany Greece Italy +4

  • Study on the Safety and Effectiveness of Pegcetacoplan for Patients with Post-Transplant Recurrence of C3 Glomerulopathy or Immune Complex Membranoproliferative Nephritis

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Italy The Netherlands

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