CLINICAL TRIAL

Obinutuzumab for Heymann Nephritis

Recruiting · 18+ · All Sexes · Haifa, Israel

This study is evaluating whether a drug may help treat a kidney disease.

See full description

About the trial for Heymann Nephritis

Eligible Conditions
Primary Membranous Nephropathy · Kidney Diseases · Glomerulonephritis, Membranous

Treatment Groups

This trial involves 2 different treatments. Obinutuzumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Diphenhydramine
DRUG
Obinutuzumab
DRUG
Methylprednisolone
DRUG
Acetaminophen
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Tacrolimus
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diphenhydramine
FDA approved
Obinutuzumab
FDA approved
Methylprednisolone
FDA approved
Acetaminophen
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening
Screening urinary protein-to-creatinine ratio (UPCR) >= 5 g/g from 24-hour urine collection after best supportive care for >= 3 months prior to screening or screening UPCR >= 4 g/g after best supportive care for >= 6 months prior to screening
eGFR >= 40 mL/min/1.73m^2 or qualified endogenous creatinine clearance >= 40 mL/min/1.73m^2 based on 24-hour urine collection during screening
Other inclusion criteria may apply
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 8 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 8 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 8 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Obinutuzumab will improve 1 primary outcome and 14 secondary outcomes in patients with Heymann Nephritis. Measurement will happen over the course of Open Label: Baseline; Escape Treatment: Week 0.

Prevalence of Anti-drug Antibodies (ADAs) to Obinutuzumab at Baseline
OPEN LABEL: BASELINE; ESCAPE TREATMENT: WEEK 0
OPEN LABEL: BASELINE; ESCAPE TREATMENT: WEEK 0
Change in anti-PLA2R Autoantibody Titer
BASELINE TO WEEK 52
BASELINE TO WEEK 52
Percentage of Participants who Achieve CR at Week 76
WEEK 76
WEEK 76
Mean Change from Baseline in the PROMIS Global Assessment of Physical Health Scale at Week 104
BASELINE TO WEEK 104
Self-reported changes in physical health will be measured using the PROMIS Physical Health Scale
BASELINE TO WEEK 104
Mean Change in T-score from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale at Week 104
BASELINE TO WEEK 104
Self-reported changes in fatigue will be measured using the PROMIS Fatigue Scale.
BASELINE TO WEEK 104
Percentage of Participants who Achieve an Overall Remission at Week 104
WEEK 104
WEEK 104
See More

Patient Q & A Section

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

Can heymann nephritis be cured?

Heyman's nephritis is most probably a disease that may persist for an extended period without cure. Close surveillance is required to anticipate new symptoms of flare-ups of an already present renal disease.

Anonymous Patient Answer

What are common treatments for heymann nephritis?

Nephritis can be treated with medications or immunosuppressive treatment. Most patients need a combination of different treatments. However, the combination of corticosteroid, mycophenolate mofetil, anakinra or rituximab is superior. There is no difference in efficacy of rituximab or tacrolimus in relapse-free, progression-free, or patient survivals. All patients with kidney transplants need long-term immunosuppressants in combination with medications and biologic agents. In most cases, patients need treatment for life.

Anonymous Patient Answer

What is heymann nephritis?

Heymann nephritis, described by the French medical term in 1889, affects a group of persons of European descent with hereditary antineutrophil cytoplasmic autoimmunity usually associated with congenital heart defects, malformations of the kidneys (kidney abnormalities), mental retardation and other developmental abnormalities. The disorder was first described by the pathologist Karl Heine Heymann (1847-1909). Heymann nephritis and granulomatous or fibrino-follicular (necro-)kidney disease share similar clinical presentations and is a manifestation of the autoimmune syndrome.

Anonymous Patient Answer

What are the signs of heymann nephritis?

While there are many specific signs and symptoms of HN, there is currently no single sign that will indicate an autoimmune disease. Instead, HN can be diagnosed if abnormalities of urinalysis, blood and kidney biopsy (in HN) and renal biopsy are consistent with antibody-mediated vasculitis and vasculitis with glomerulopathy is confirmed.

Anonymous Patient Answer

What causes heymann nephritis?

The cause of Heymann nephritis is a mixture of factors, rather than a single agent or cause. A major factor was certainly related to genetics. Some other factors are thought to have been due to immunologic dysfunction (inflammation) in the kidney. A genetic predisposition may help explain the increased incidence among people with HLA-DR3.

Anonymous Patient Answer

How many people get heymann nephritis a year in the United States?

Between 1994 and 2007, the reported incidence of HN varied widely. Although an increase in the rate of HN has been documented in some population-based registries, others report no discernible increase. A variety of factors may explain this phenomenon, including subtle changes in diagnostic criteria, changes in the frequency of HN, or changes in medical management of patients with renal disease. Further studies are needed to elucidate these important issues.

Anonymous Patient Answer

Who should consider clinical trials for heymann nephritis?

A study of a limited cohort of patients with HKD showed no correlation between demographic parameters, histological findings, severity, or clinical presentation, and enrollment into a clinical trial, or the response to treatment. The main reasons for proceeding to RCT were patients' subjective complaints and the need to prevent progressive renal destruction. The response to treatment was limited to a small group of patients in whom renal function remained stable and, more importantly, to the patients who benefited from intensive therapy. Clinical trials should be considered only for patients with severely progressive AKD, or for whom RCT may be of benefit.

Anonymous Patient Answer

What is the latest research for heymann nephritis?

This article reviews current research on the treatment of Heymann nephritis. We hope that it will help you understand and treatment this condition and avoid many complications. (https://www.dartmouth.edu/fractures-pediatrics/heymannns/what-is-heymns/).

Anonymous Patient Answer

Have there been any new discoveries for treating heymann nephritis?

There are several new discoveries for treating HN. There are several types of immunomodulatory agents such as monoclonal antibodies that are being tested. As of now there is no conclusive evidence on whether these compounds are a cure or improvement to the disease severity. However, they do show great potential for new treatments for the disease. Immunoglobulin (Ig) is a compound that is being studied as a medication for treating HN. There are specific antibody that are being studied as a therapy in people's life-spans and ages such as anti-platelet receptors and Fc receptors on macrophages. These different types of antibody are very safe and can only help with the HN disease.

Anonymous Patient Answer

Does heymann nephritis run in families?

Heymann nephritis does have an impact on family life and this should be taken into account when assessing the value of familial studies as a means of identifying susceptibility genes.

Anonymous Patient Answer

How serious can heymann nephritis be?

Untreated Heymann nephritis can cause progressive [kidney dysfunction, kidney failure, and death], but treatment with the right immunosuppressive drug at the right time can prevent death.

Anonymous Patient Answer

Have there been other clinical trials involving obinutuzumab?

Obinutuzumab had previously been investigated in the treatment of patients with chronic active steroid-refractory rheumatic diseases and severe active/active lupus nephritis. This drug was originally designated CUBIC-001 in early phase III clinical trials with patients with severe active/active lupus nephritis. In one of these trials, patients on therapy with obinutuzumab (obinutuzumab) had a 50% reduction in the necessity for renal transplantation (from 21% to 11%) compared with those on placebo therapy (from 25% to 26%).

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Heymann Nephritis by sharing your contact details with the study coordinator.