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Glomerulonephritis clinical trials

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NCT ID: NCT01560052 Completed - Clinical trials for IgA Glomerulonephritis

Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study)

TESTING
Start date: May 5, 2012
Phase: N/A
Study type: Interventional

This study will evaluate the long-term efficacy and safety of low dose oral methylprednisolone compared to matching placebo, on a background of routine RAS inhibitor therapy, in preventing kidney events in patients with IgA nephropathy and features suggesting a high risk of progression.

NCT ID: NCT01282073 Recruiting - Clinical trials for Glomerulonephritis, Membranous

Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy

MMFPRIMER
Start date: March 2011
Phase: Phase 3
Study type: Interventional

Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a reasonable alternative with fewer side effect.

NCT ID: NCT01240564 Recruiting - Kidney Disease Clinical Trials

The Nephrotic Syndrome Study Network (NEPTUNE)

Start date: October 2010
Phase: N/A
Study type: Observational

Background: - The Nephrotic Syndrome Study Network (NEPTUNE) is a network of multidisciplinary researchers who are investigating why kidney disease happens. NEPTUNE researchers will collect kidney tissue and other samples (for example, blood and urine) from individuals who are scheduled to have kidney biopsies to determine the cause of protein in the urine (only one kidney biopsy is necessary). Objectives: - To collect kidney tissue, other samples, and data /information for continuing research into kidney diseases. Eligibility: - Individuals at least 18 years of age who need to have a kidney biopsy to determine the cause of protein in the urine, do not have a systemic disease that is the cause of the their kidney disease, and have not received specific treatment for kidney disease. Design: - This study involves a screening and baseline visit and additional followup visits after the kidney biopsy. - Participants will be screened with a medical history and physical examination, as well as blood and urine samples and collection of fingernail clippings. Participants will also complete questionnaires about their history of kidney problems. - During the kidney biopsy, performed at the NIH Clinical Center, researchers will take an additional tissue sample for research. - Participants will return for followup visits at NIH every 4 months in the first year, and every 6 months in the second through fifth years after the biopsy. Additional blood and urine samples will be collected at each visit, and fingernail clippings will also be collected annually by the study researchers. - Treatment for kidney disease will not be provided as part of this protocol and instead will generally be provided by the patient s own physician. Compensation: Subjects received compensation for each visit to the NIH Clinical Center.

NCT ID: NCT01221181 Completed - Clinical trials for Dense Deposit Disease

Eculizumab Therapy for Dense Deposit Disease and C3 Nephropathy

Start date: July 2010
Phase: Phase 1
Study type: Interventional

This open label, non-blinded, proof of concept efficacy and safety study of eculizumab in patients with biopsy proven DDD or C3 nephropathy. The trial will consist of adult patients with these diseases who have > 1 gram of proteinuria or a decreased glomerular filtration rate (GFR), both predictors of a poor long-term outcome in many glomerular diseases. The patients will be treated with eculizumab for one year. The goals will be to determine whether treatment leads to an improvement in kidney function, defined by remissions of proteinuria and improvements in estimated GFR (measured by serum creatinine), and to improvement in histologic parameters, including percentage of non-affected glomeruli, interstitial fibrosis, intensity of C3 staining of immunofluorescence, and amount of electron dense deposits by electron microscopy.

NCT ID: NCT01184599 Recruiting - Hypertension Clinical Trials

A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy

Start date: June 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin inhibitor, on renal function and progress of renal disease in hypertensive patients with IgA nephropathy.

NCT ID: NCT01129557 Terminated - Clinical trials for Diabetic Nephropathy

Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease

Start date: September 2009
Phase: Phase 4
Study type: Interventional

Primary Hypothesis: Aldosterone breakthrough will occur at a far lower frequency during renin inhibition (0-10% over 9 months), alone or in combination with an ARB, compared to conventional ARB therapy (35-45% over 9 months). The investigators hypothesize that aldosterone breakthrough occurs due to accumulation of active precursor substances, most notably angiotensin II, produced in response to conventional RAAS blockade with ACEinhibitors and ARBs. The investigators believe that direct renin inhibition (DRI) should minimize this accumulation and therefore significantly lower or possibly eliminate the breakthrough effect. Interruption of the renin-angiotensin-aldosterone system (RAAS) with angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin receptor blockers (ARBs), alone and in combination, has become a leading therapy to slow the progression of chronic heart and kidney disease. Both types of drugs inhibit the formation of aldosterone, a hormone, which has been shown to have harmful effects on patients with chronic heart and kidney disorders. This treatment is effective but not perfect since, even after an initial improvement, many patients become worse over the long term. This may be due to an unexpected increase in aldosterone, a phenomenon called "aldosterone breakthrough." The purpose of this study is to find out whether the use of a direct renin inhibitor (DRI) alone, or in combination with an angiotensin receptor blocker (ARB), will lessen the occurrence of aldosterone breakthrough since direct renin inhibitors inhibit the formation of aldosterone at a very early step. This study will compare the effectiveness of adding Diovan (valsartan) or Tekturna (aliskiren) or a combination of Diovan and Tekturna to the usual antihypertensive treatment. The investigators will follow blood pressure, aldosterone levels, and urinary protein levels over 9 months to evaluate which of these therapies is most effective for treating hypertension in patients with proteinuric kidney disease.

NCT ID: NCT01115426 Completed - Clinical trials for IGA Glomerulonephritis

Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis

Start date: January 1997
Phase: Phase 4
Study type: Interventional

This study evaluates prospectively the effects of an anti-angiotensin II regimen on renal outcome in patients with mesangioproliferative glomerulonephritis followed-up for 10 years.

NCT ID: NCT01093157 Completed - Glomerulonephritis Clinical Trials

A Dose Escalation Study of Long-acting ACTH Gel in Membranous Nephropathy

Start date: February 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Membranous Nephropathy (MN) is an immune-mediated kidney disease that affects the glomerulus or the filter that removes toxins from the blood. Damage to the membrane that separates blood from urine results in loss of protein into the urine (proteinuria) and in some cases loss of kidney function.There is no standard specific treatment for MN. ACTH has a pronounced lipid-lowering effect in healthy individuals, in steroid-treated patients with renal disease and in hemodialysis patients Some studies suggest that prolonged synthetic ACTH therapy may represent an effective therapy in patients with idiopathic MN, more extensive randomized studies with longer follow-up are needed before therapeutic recommendations can be made. We propose to do a pilot study to test the hypothesis that biologic ACTH, a slow-release formulation of corticotropin extracted from porcine pituitary glands (H.P. Acthar gel) will be effective in reducing proteinuria and improving lipid profile in patients with idiopathic MN.

NCT ID: NCT00983034 Completed - Nephrotic Syndrome Clinical Trials

The Effects of Helicobacter Pylori Eradication on Proteinuria in Patients With Membranous Nephropathy

Start date: March 2006
Phase: N/A
Study type: Interventional

Membranous nephropathy (MN) may also be secondary to many other diseases (e.g., infections, drugs, neoplasms and autoimmune diseases). In this study, the presence of Helicobacter Pylori (H. pylori) antigen was investigated in renal tissue from needle biopsy samples, and the prevalence of H. pylori infection and the effects of H. pylori eradication on proteinuria level in patients with MN will be investigated.

NCT ID: NCT00977977 Recruiting - Proteinuria Clinical Trials

Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy

Start date: December 22, 2010
Phase: Phase 2
Study type: Interventional

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.