Ongoing Clinical Trials for Nephropathy
Currently, there are 3 ongoing clinical trials investigating new treatments for nephropathy. These studies are exploring different medications to help manage various forms of kidney disease, including chronic kidney disease, IgA nephropathy, and post-transplant kidney conditions. The trials are being conducted across multiple countries in Europe, offering patients opportunities to access experimental treatments that may help slow disease progression and improve kidney function.
Clinical trial locations
- Austria
- Belgium
- Croatia
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Netherlands
- Norway
- Poland
- Spain
- Sweden
Study on Colchicine and Opium for Preventing Heart and Kidney Issues in Patients with Moderate Chronic Kidney Disease
This study is investigating colchicine, a medication that may help prevent heart and blood vessel problems in people with moderate chronic kidney disease. The trial aims to determine whether taking a low dose of colchicine daily can slow down the progression of kidney damage and reduce the risk of serious heart-related complications.
Main inclusion criteria: To participate, you must be between 18 and 99 years old with moderate chronic kidney disease, indicated by a glomerular filtration rate between 30 and 59. You must also have a history of a cardiovascular event, such as acute coronary syndrome, hospitalization for angina, a transient ischemic attack, stroke, coronary revascularization, peripheral blood vessel problems, or evidence of coronary artery disease on imaging tests. You must be willing and able to provide informed consent.
Main exclusion criteria: You cannot participate if you have chronic renal disease outside the specified parameters, are not within the required age range, or belong to a vulnerable population requiring special protection.
Focus and goals: The study monitors participants for heart-related events including heart attacks, strokes, and conditions requiring hospitalization or surgery, while also assessing changes in kidney function over time. The treatment period extends through July 2027, with regular health assessments throughout.
Investigational drug: Colchicine is administered orally at a dose of 0.5 mg per day. It works as an anti-inflammatory agent by disrupting microtubule formation, which affects various cellular processes including inflammation. The medication is being tested to see if it can reduce the risk of serious cardiovascular events and slow kidney disease progression.
Study on the Effects of Povetacicept for Adults with IgA Nephropathy
This trial focuses on testing povetacicept injection for adults with IgA nephropathy, a condition that occurs when the antibody immunoglobulin A builds up in the kidneys, causing inflammation and potentially leading to kidney damage over time. The study will evaluate whether this medication can reduce protein levels in urine and help preserve kidney function.
Main inclusion criteria: Eligible participants must have a diagnosis of IgA nephropathy confirmed by kidney biopsy, with 24-hour urine protein excretion of at least 1.0 gram per day or a protein-to-creatinine ratio of at least 0.75 grams per gram. You must have an estimated glomerular filtration rate of at least 30 mL/min/1.73m2 and be on a stable dose of an ACE inhibitor or ARB medication. Both males and females within the specified age range can participate.
Main exclusion criteria: You cannot participate if you have any kidney disease other than IgA nephropathy, have had a kidney transplant, have severe liver disease, uncontrolled high blood pressure, are pregnant or breastfeeding, have had cancer in the last 5 years, have a known allergy to the study medication, are currently in another clinical trial, have a history of drug or alcohol abuse in the past year, or have any serious medical condition that might interfere with the study.
Focus and goals: The study lasts 104 weeks, during which participants receive either povetacicept or placebo through subcutaneous injections. Regular follow-up visits monitor kidney function, protein levels in urine, and overall safety. The main goal is to determine if povetacicept can effectively slow the progression of kidney disease in people with IgA nephropathy.
Investigational drug: Povetacicept is given as an injection under the skin and works as an immunomodulatory agent, helping to regulate immune system activity. By modulating the immune system, it aims to prevent further kidney damage and reduce protein levels in urine, thereby helping maintain kidney function.
Study on the Safety and Effectiveness of Pegcetacoplan for Patients with Post-Transplant Recurrence of C3 Glomerulopathy or Immune Complex Membranoproliferative Nephritis
This trial is evaluating pegcetacoplan for patients who have experienced a recurrence of either complement 3 glomerulopathy or immune complex membranoproliferative glomerulonephritis after kidney transplant. Both conditions involve the immune system attacking the transplanted kidney, leading to inflammation and damage.
Main inclusion criteria: You must be at least 18 years old and have confirmed diagnosis of recurrent C3G or IC-MPGN in your kidney transplant, verified by kidney biopsy. The condition must be primary, not caused by infection, cancer, or other immune disorders. Your disease should be stable or worsening in the two months before treatment begins. You must have an estimated glomerular filtration rate of at least 15 mL/min/1.73 m2, with no more than 50% kidney tissue scarring. You need to be on stable treatment for at least four weeks before starting and must have received required vaccinations against certain bacteria or agree to vaccination. Women of childbearing potential must use specific birth control methods, and men must also follow contraception requirements.
Main exclusion criteria: You cannot participate if you have a different kidney condition than those being studied, are outside the specified age range, cannot follow study procedures or take medication as required, have medical conditions that could interfere with results, are pregnant or breastfeeding, participated in another recent clinical trial, have allergic reactions to the study medication, have serious illness affecting study participation, or are unable to provide informed consent.
Focus and goals: The study administers pegcetacoplan via subcutaneous injection over an initial 12-week period, with possible extension up to 52 weeks. The primary goal is to observe reduction in kidney tissue damage markers. Regular assessments monitor kidney function, safety, and overall treatment effectiveness throughout the study period.
Investigational drug: Pegcetacoplan is administered through injection under the skin using an ambulatory syringe infusion system. It works as a complement inhibitor, targeting part of the immune system that contributes to inflammation and tissue damage in these kidney conditions. The medication is being studied in Phase 2 clinical trials to assess its ability to improve kidney health in patients with post-transplant recurrence of these rare kidney diseases.
Summary
These three clinical trials represent diverse approaches to treating different forms of kidney disease. One study is being conducted exclusively in Spain, while another spans 19 European countries, offering broader access to patients with IgA nephropathy. The third trial is available in Austria, Netherlands, and Italy, focusing on post-transplant complications.
The trials investigate three different medications with distinct mechanisms of action: colchicine as an anti-inflammatory agent for chronic kidney disease with cardiovascular risk, povetacicept as an immunomodulatory treatment for IgA nephropathy, and pegcetacoplan as a complement inhibitor for rare post-transplant kidney conditions. Each study addresses specific patient populations with varying disease severity and treatment goals, from preventing cardiovascular complications to preserving kidney function and managing post-transplant recurrence.
Patients interested in participating should discuss eligibility with their healthcare providers and consider the specific requirements and commitments involved in each trial.
