Study on the Safety and Effects of AP1189 for Patients with Idiopathic Membranous Nephropathy and Severe Proteinuria

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What is this study about?

This clinical trial is focused on studying a kidney condition known as idiopathic membranous nephropathy, which is characterized by severe protein loss in the urine, a condition called severe proteinuria. The trial is testing a new treatment called the AP1189 Tablet, which contains the active substance resomelagon. This treatment is being compared to a placebo to see how safe and effective it is when used alongside standard treatments like ACE inhibitors or angiotensin II receptor blockers, which are commonly used to manage blood pressure and kidney function.

The purpose of the study is to evaluate the safety and effectiveness of the AP1189 Tablet over a period of 12 weeks. Participants will receive either the AP1189 Tablet or a placebo daily. Throughout the study, researchers will monitor participants’ health by checking for any side effects, changes in vital signs, and conducting tests like electrocardiograms and laboratory assessments. The main focus will be on how the treatment affects the amount of protein lost in urine over the 12-week period.

Participants will be closely observed to see if there are any improvements in their condition, such as a reduction in protein loss or improvements in kidney function. The study will also look at changes in other health markers, like albumin levels in the blood and kidney filtration rates. The goal is to determine if the AP1189 Tablet can help manage the symptoms of idiopathic membranous nephropathy more effectively than current treatments alone.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the AP1189 tablet or a placebo tablet. The placebo is a tablet that looks like the AP1189 tablet but does not contain the active substance.

The study is designed to be double-blind, meaning neither you nor the study team will know which tablet you are receiving. This helps ensure the results are unbiased.

2 medication administration

You will take the assigned tablet orally once daily for a period of 12 weeks. It is important to take the tablet at the same time each day to maintain consistency.

The study aims to assess the safety and effectiveness of the AP1189 tablet in addition to your current treatment with ACE inhibitors or angiotensin II receptor blockers.

3 monitoring and assessments

Throughout the 12-week period, you will undergo regular assessments to monitor your health and the effects of the treatment. These assessments will include checking your vital signs, conducting electrocardiograms (a test that measures the electrical activity of your heart), and performing laboratory tests.

You will also be asked to provide urine samples to measure changes in urinary protein excretion and other related parameters. This helps evaluate the impact of the treatment on your condition.

4 end of treatment

At the end of the 12-week treatment period, a final set of assessments will be conducted to determine the effects of the treatment. This includes measuring changes in your urinary protein excretion from the start to the end of the study.

You will also have a follow-up visit four weeks after the last dose to assess any lasting effects of the treatment.

Who Can Join the Study?

Written informed consent must be obtained before starting any study-specific procedures.
Participants must be male or female, aged between 18 and 85 years, with idiopathic membranous nephropathy (iMN) and severe proteinuria (high levels of protein in the urine).
Participants must be diagnosed as anti-PLA2-Receptor positive by a local laboratory within 6 months before joining the study, or have a kidney biopsy consistent with iMN within 24 months before joining.
Participants must have severe proteinuria, defined by a U-protein/creatinine ratio greater than 3.0 g/g and/or a U-albumin/creatinine ratio greater than 2.0 g/g, and P-albumin below the lower normal limit.
Participants must have an eGFR (a measure of kidney function) greater than 30 ml/min/1.73m².
Participants must have been treated with ACE inhibitors or angiotensin II receptor blockers for at least 1 month with stable blood pressure, or these treatments must have been excluded or stopped due to low blood pressure, intolerance, or other side effects.
Females of child-bearing potential must use reliable contraception or be postmenopausal (no menstrual periods for at least 12 months) or be surgically sterilized (procedure done at least 6 months before screening).
Females of child-bearing potential must have a negative pregnancy test at screening and baseline.
Post-menopausal women (no menstrual periods for at least 12 months) or women who are surgically sterilized (procedure done at least 6 months before screening).

Who Cannot Join the Study?

Patients with any other kidney disease besides idiopathic membranous nephropathy cannot participate. This is a condition where the kidney filters are damaged, leading to protein loss in urine.
Patients with severe proteinuria that is not related to idiopathic membranous nephropathy are excluded. Proteinuria means having too much protein in the urine.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.
Patients who have any medical condition or are taking any medication that might interfere with the study results are excluded.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with a history of serious allergic reactions to any of the study medications cannot participate.
Patients who are pregnant or breastfeeding are not eligible for the study.
Patients with any condition that the study doctors believe would make it unsafe for them to participate are excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Region Midtjylland	Aarhus	Denmark
Rmoyzb Nqumzhuzzfv	Aalborg	Denmark
Ubnheagxkbvcrpyisnz Sbuxv	Lund	Sweden
Hwkjmq Hkjjigwq	Herlev	Denmark
Rbcjcr Sathiswhge	Vejle	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.06.2020
Sweden	Recruiting	01.06.2020

Trial locations

Investigated drugs:

Resomelagon

AP1189 is a medication being tested in this clinical trial. It is being studied to see if it can help people with a kidney condition called idiopathic membranous nephropathy, which causes the kidneys to leak too much protein into the urine. This medication is being added to the treatment that patients are already receiving, which includes either an ACE inhibitor or an angiotensin II receptor blocker. The trial aims to find out if AP1189 is safe and if it can reduce the amount of protein in the urine over a 12-week period.

Investigated diseases:

Nephrotic syndrome

Idiopathic Membranous Nephropathy – Idiopathic membranous nephropathy is a kidney disorder characterized by the thickening of the membranes within the glomeruli, which are tiny blood vessels in the kidneys. This thickening is due to the accumulation of immune deposits, which can interfere with the kidney’s ability to filter waste and excess fluid from the blood. As the disease progresses, it often leads to significant protein loss in the urine, a condition known as proteinuria. Over time, this protein loss can cause swelling in various parts of the body, particularly in the legs and around the eyes. The disease can also lead to changes in blood pressure and kidney function. The progression of idiopathic membranous nephropathy can vary, with some individuals experiencing a slow decline in kidney function while others may have periods of remission.

Trial ID:

2024-518384-36-00

Protocol code:

SynAct-CS003

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of AP1189 for Patients with Idiopathic Membranous Nephropathy and Severe Proteinuria

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?