Clinical Trials
Open studies conducted by NIDDK Principal Investigators appear below. Study statuses may include the following:
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Open: Recruiting - Currently recruiting participants and open to everyone who meets eligibility criteria.
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Open: Active, Not Recruiting - Participants are receiving an intervention or being examined, however new participants
are not being recruited or enrolled.
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Open: Enrolling by Invitation - People in a particular population were selected in advance and invited to participate.
The study is not open to everyone who meets the eligibility criteria.
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Open: Available for Expanded Access - Patients who are not participants in the clinical study may be able to
gain access to the drug, biologic, or medical device being studied.
Studies Seeking Patients
The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete or partial remission (CR or PR) compared to rituximab alone in participants with primary membranous nephropathy.
Background:
Primary membranous nephropathy (MN) is among the most common causes of nephrotic syndrome in adults. MN affects individuals of all ages and races. The peak incidence of MN is in the fifth decade of life.
Primary MN is recognized to be an autoimmune disease, a disease where the body's own immune system causes damage to kidneys. This damage can cause the loss of too much protein in the urine.
Drugs used to treat MN aim to reduce the attack by one's own immune system on the kidneys by blocking inflammation and reducing the immune system's function. These drugs can have serious side effects and often do not cure the disease. There is a need for new treatments for MN that are better at improving the disease while reducing fewer treatment associated side effects.
In this study, researchers will evaluate if treatment with a combination of two different drugs, belimumab and rituximab, is effective at blocking the immune attacks on the kidney compared to rituximab alone. Rituximab works by decreasing a type of immune cell, called B cells. B cells are known to have a role in MN. Once these cells are removed, disease may become less active or even inactive. However, after stopping treatment, the body will make new B cells which may cause disease to become active again.
Belimumab works by decreasing the new B cells produced by the body and, may even change the type of new B cells subsequently produced. Belimumab is approved by the US Food and Drug Administration (FDA) to treat systemic lupus erythematosus (also referred to as lupus or SLE). Rituximab is approved by the FDA to treat some types of cancer, rheumatoid arthritis, and vasculitis. Neither rituximab nor belimumab is approved by the FDA to treat MN. Treatment with a combination of belimumab and rituximab has not been studied in individuals with MN, but has been tested in other autoimmune diseases, including lupus nephritis and Sjögren's syndrome.
The trial is Open with a status of Active, not recruiting.
Investigator:
Meryl A Waldman, M.D., Patrick Nachman, M.D., Iñaki Sanz, M.D.
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Background:
- Membranous nephropathy is associated with damage to the walls of the glomeruli, the
small blood vessels in the kidneys that filter waste products from the blood. This
damage causes leakage of blood proteins into the urine and is associated with low blood
protein levels, high blood cholesterol values, and swelling of the legs. These problems
can decrease or go away without treatment in about 25 percent of patients, but if they
persist, some patients may experience impaired (or loss of) kidney function, blood
vessel and heart disease, and a risk of forming blood clots in veins.
- Kidney biopsies that show that antibodies have been deposited along the glomeruli
suggest that specialized cells of the immune system, called B and T cells, are causing
damage to the kidneys through their increased activity. To suppress the action of B and
T cells and to decrease the harmful deposits in the kidneys, drug treatments are
required.
- Patients with membranous nephropathy are often treated with immunosuppressive drugs such
as cyclosporine or cytoxan plus steroids that attempt to reduce or suppress the activity
of the immune system, decrease antibody production, and reduce antibody deposits in the
kidney. However, not everyone responds to these medications and the kidney disease can
return in some patients when the drugs are stopped. Also, there are side effects
associated with long term usage of these medications. Rituximab, a different
immunosuppressant, has also been used for this purpose. Although cyclosporine and
Rituximab have been used separately, they have not been tried in combination as a
possible treatment for membranous nephropathy.
Objectives:
- To determine the safety and effectiveness of combining rituximab and cyclosporine to treat
membranous nephropathy.
Eligibility:
- Individuals 18 years of age and older who have been diagnosed with membranous nephropathy
based on a kidney biopsy done within the preceding 24 months, and who have had excess levels
of protein in the urine for at least 6 months based on urine and blood tests.
Design:
- Potential participants will be screened with an initial clinic evaluation and full
medical history.
- Before the treatment, there will be a run-in period that will last up to 2 months.
During this time, participants will be placed on a blood pressure lowering medication
and will not take any other immunosuppressant medications.
- Participants will visit the NIH clinical center for a baseline evaluation, four
intravenous infusions of rituximab, and also at 1- to 6-month intervals throughout the
study.
- Active treatment period will involve a 6-month course of cyclosporine and a total of
four doses of rituximab. Participants will take cyclosporine tablets twice daily, and
have two infusions of rituximab given 2 weeks apart, After 6 months, the cyclosporine
dose will slowly be decreased over several weeks and then completely discontinued.
Participants will then receive another course (two doses 2 weeks apart) of rituximab,
depending on results of blood work.
- Participants will have frequent blood and urine tests performed to monitor the results
of treatment and reduce the chance of side effects.
The trial is Open with a status of Recruiting.
Investigator:
Meryl A Waldman, M.D.
Referral Contacts:
Meryl A Waldman, M.D.
(301) 451-6990
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Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis,
membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue
disorders.
This study will allow researchers to admit and follow patients suffering from autoimmune
diseases of the kidney. It will attempt to provide information about the causes and specific
abnormalities associated with autoimmune kidney disease.
Patients with kidney disease as a result of their immune system, and patients with diseases
of the immune system who may later develop kidney disease, will be potential subjects for
this study.
Patients will undergo a history and physical examination, and standard laboratory test to
more closely understand the causes, signs, symptoms, and responses to medication of these
diseases. Based on these evaluations the patients may qualify as candidates for other
experimental studies. At any time these patients may be asked to submit blood or urine
samples for further research.
The trial is Open with a status of Recruiting.
Investigator:
Meryl A Waldman, M.D.
Referral Contacts:
Meryl A Waldman, M.D.
(301) 451-6990
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Last Reviewed October 2024