Not recruitingRare disease

Study on the Effectiveness and Safety of Obinutuzumab and Tacrolimus for Patients with Primary Membranous Nephropathy

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a kidney condition known as Primary Membranous Nephropathy (pMN). The study is evaluating the effectiveness and safety of a medication called Obinutuzumab, which is compared to another treatment known as Tacrolimus. Obinutuzumab is given as an infusion, which means it is administered directly into the bloodstream through a vein, while Tacrolimus is taken orally in the form of capsules.

The purpose of the study is to determine how well Obinutuzumab works compared to Tacrolimus in helping patients achieve a complete remission, which means the symptoms of the disease are significantly reduced or disappear. The study will last for a period of 104 weeks, during which participants will receive either Obinutuzumab or Tacrolimus. Throughout the study, participants will be monitored to see how their condition responds to the treatment and to check for any side effects.

Participants will be assessed at various points during the study to see if they achieve remission and to monitor their overall health. The study aims to provide valuable information on the potential benefits and risks of using Obinutuzumab for treating Primary Membranous Nephropathy, which could help improve treatment options for patients with this condition in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The study begins with the administration of obinutuzumab, a medication given through an intravenous (IV) infusion. This phase is designed to evaluate the initial response to the treatment.
Step 2
Oral medication phase
Following the initial treatment, tacrolimus is administered orally. The dosage and frequency are determined by the study protocol and are adjusted based on individual response and tolerance.
Step 3
Monitoring and assessment
Throughout the study, regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes measuring the urinary protein-to-creatinine ratio (UPCR) and evaluating kidney function.
Blood tests are performed to monitor serum concentrations of obinutuzumab and to check for any adverse effects.
Step 4
Evaluation of remission
The primary goal is to achieve a complete remission (CR) by Week 104. This involves a significant reduction in protein levels in the urine and stabilization of kidney function.
Secondary evaluations include overall remission rates, time to treatment failure, and changes in fatigue and physical health as reported by patients.
Step 5
Final assessment
At the end of the study period, a comprehensive assessment is conducted to determine the long-term effects of the treatment. This includes evaluating the duration of remission and any changes in health status.
The study also examines the incidence and severity of any adverse events experienced during the trial.

Who can join the trial?

7 criteria

Must be able to follow the study rules, as judged by the study doctor.
Must have a diagnosis of Primary Membranous Nephropathy (pMN), confirmed by a kidney biopsy either before or during the screening process.
Must have a certain level of protein in the urine, measured as a urinary protein-to-creatinine ratio (UPCR) of at least 5 grams per gram from a 24-hour urine collection after receiving the best supportive care for at least 3 months before screening, or a UPCR of at least 4 grams per gram after receiving the best supportive care for at least 6 months before screening.
Must have a certain level of kidney function, measured as an estimated glomerular filtration rate (eGFR) of at least 40 milliliters per minute per 1.73 square meters, or a qualified endogenous creatinine clearance of at least 40 milliliters per minute per 1.73 square meters, based on a 24-hour urine collection during screening.
Patients who previously responded to certain treatments like calcineurin inhibitors (CNIs), rituximab, or alkylating agents with either a complete or partial remission and then had the disease return can participate. However, they must have stopped using CNIs or alkylating agents for at least 6 months and rituximab for at least 9 months before screening.
For patients joining the extended China enrollment phase at sites in China: must currently live in mainland China and be of Chinese ancestry.
Both male and female participants are eligible.

Who cannot join the trial?

8 criteria

Patients who have a different kidney condition other than Primary Membranous Nephropathy (pMN) cannot participate. Primary Membranous Nephropathy is a kidney disease that affects the filtering units of the kidneys.
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 not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible to participate.
Patients who have allergies or reactions to the study medications cannot participate.
Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Federico II Di Napoli
Verified
Naples, Italy
Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Responsive
Lodz, Poland

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Investigated drugs

Obinutuzumab
is a medication used in this trial to treat patients with primary membranous nephropathy. It is designed to target and bind to specific cells in the immune system, helping to reduce inflammation and damage to the kidneys. The goal of using obinutuzumab in this study is to see if it can help patients achieve complete remission of their symptoms.
Tacrolimus
is another medication being compared in this trial. It is commonly used to suppress the immune system and prevent it from attacking the body's own tissues. In this study, tacrolimus is used to see how effective it is in helping patients with primary membranous nephropathy achieve complete remission of their symptoms.

What is already known about the treatment

Obinutuzumab
This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating Primary Membranous Nephropathy (pMN). Obinutuzumab works by targeting and binding to a specific protein on the surface of certain immune cells, leading to their destruction. It is classified as a monoclonal antibody, which is a type of targeted therapy designed to interfere with specific pathways in the immune system.
Tacrolimus
This medication is typically taken orally in the form of capsules. It is being compared to obinutuzumab in clinical trials for its use in treating Primary Membranous Nephropathy (pMN). Tacrolimus acts by inhibiting certain immune cells, thereby reducing inflammation and immune response. It belongs to the pharmacological class of calcineurin inhibitors, which are commonly used to prevent organ rejection in transplant patients and to treat autoimmune conditions.

Investigated diseases

Primary Membranous Nephropathy – This is a kidney disorder characterized by the thickening of the membranes within the glomeruli, which are tiny blood vessels in the kidneys. It is an autoimmune condition where the body's immune system mistakenly attacks the kidneys, leading to damage. Over time, this damage can cause protein to leak into the urine, a condition known as proteinuria. The disease often progresses slowly, and symptoms may not be noticeable in the early stages. As it advances, individuals may experience swelling, particularly in the legs and ankles, due to fluid retention. The progression of the disease can vary, with some individuals experiencing spontaneous remission while others may have persistent symptoms.