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Nephrosis clinical trials

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NCT ID: NCT00362531 Completed - Nephrotic Syndrome Clinical Trials

Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome

Start date: November 2004
Phase: Phase 2/Phase 3
Study type: Interventional

Idiopathic membranous nephropathy (IMN) is one of the most common forms of nephrotic syndrome (NS) in adults and is usually treated by corticosteroids in combination with cytotoxic drugs especially cyclophosphamide or cyclosporine. Tacrolimus, a new immunosuppressive agent, was proved to be effective in treating refractory NS. Whether it is effective in IMN has not been reported. We therefore undertook a multi-center, controlled study to investigate the efficacy and safety profile of tacrolimus compared with cyclophosphamide in the treatment of patients with idiopathic membranous nephropathy and nephrotic syndrome.

NCT ID: NCT00354731 Completed - Nephrotic Syndrome Clinical Trials

Efficacy of Pentoxifylline on Primary Nephrotic Syndrome

Start date: August 2006
Phase: Phase 3
Study type: Interventional

We aim to investigate (1) the effects of combined pentoxifylline and corticosteroids, compared to that of corticosteroids, on patients with primary nephrotic syndrome; and if possible (2) the effects of pentoxifylline monotherapy on patients with primary nephrotic syndrome not suitable for or intolerant of standard corticosteroid therapy.

NCT ID: NCT00308321 Recruiting - Nephrotic Syndrome Clinical Trials

Long Term Tapering or Standard Steroids for Nephrotic Syndrome

Start date: September 2003
Phase: Phase 4
Study type: Interventional

Parallel group double blind randomised in patients with first episode corticosteroid sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a longer tapering steroid regimen with standard regime

NCT ID: NCT00289328 Completed - Crohn's Disease Clinical Trials

Glucocorticoid-induced Osteopenia in Children

Start date: November 2001
Phase: N/A
Study type: Observational

The purpose of this study is to characterize the skeletal deficits and risk factors for impaired skeletal development in children requiring glucocorticoid therapy. We will compare the bone health of children treated with prednisone for nephrotic syndrome (NS with those treated with prednisone for Crohn's Disease (CD). Childhood NS usually responds to prednisone and is not characterized by pathologies that can impact on bone. In contrast, CD is treated with prednisone, but is independently associated with poor growth and maturation, nutritional deficiencies and inflammation. Due to the differences in the diseases, this comparison will allow us to distinguish between the prednisone-related and disease-related effects on bone in the two disease states.

NCT ID: NCT00286910 Completed - Nephrotic Syndrome Clinical Trials

Urinary Aquaporin 2 and Expression of the NPHS2 Gene in Adults Suffering From Nephrotic Syndrome

Start date: May 2005
Phase: Phase 4
Study type: Observational

We want to test the hypothesises that patients with nephrotic syndrome have a higher excretion of AQP2 in the urine,that they have a higher concentration of AVP,and a lower C-H2O.Everything will normalize, when the syndrome is in remission.Furthermore we want to test the hypothesis that the expression of mutations in the NPHS2-gene,that codes for podocin,will cause a lack off or a poorer response in the treatment of nephrotic syndrome

NCT ID: NCT00255398 Completed - Kidney Disease Clinical Trials

Kidney Disease Biomarkers

Start date: November 10, 2005
Phase:
Study type: Observational

Kidney Disease Biomarkers Summary: This study will identify biomarkers (proteins and other molecules in the blood or urine) that may help scientists predict what kidney disease a patient has and whether a given patient would respond to particular therapies. The study will look for biomarkers in the blood and urine of patients with various kidney diseases and study of the effects of angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARB) on biomarkers. Blood and urine from healthy volunteers will be studied for comparison. Healthy people and the following patients may be eligible for this study: adults with diabetic nephropathy 18 years of age and older; children with newly diagnosed clinical idiopathic nephrotic syndrome between 2 and 18 year of age; children and adults with glomerular disease (minimal change disease, focal segmental glomerulosclerosis, or collapsing glomerulopathy). Participants undergo tests and procedures as follows: Glomerular Disease: Adults with glomerular disease provide about four to six blood and urine samples over the course of 6 to 12 months. The samples are collected at the time of regularly scheduled visits for the NIH treatment protocol in which they are participating. Children provide only blood samples. Chronic Kidney Disease: Patients with chronic kidney disease provide a blood and urine sample every 6 months for 3 years or more. Angiotensin Antagonism: Patients with chronic kidney disease who are taking ACE inhibitors or ARBs stop their medicines for 4 weeks, while those who are not taking ACE inhibitors or ARBs begin one of the medicines. In general, patients just starting on the medications continue them after the study is completed, since they are beneficial for chronic kidney disease. - Medication withdrawal group: Patients come to NIH for 2 successive days at the beginning of the study for blood and urine tests (including one 24-hour urine collection) and to receive iothalamate (a chemical used to measure kidney function). Iothalamate is delivered over 24 hours through a needle placed in the abdomen (or elsewhere) via a pump similar to pumps that some diabetics use to deliver insulin. Patients then stop taking their ACE inhibitor or ARB medication. They monitor their blood pressure every day and return to NIH after 1, 2 and 4 weeks for blood tests. During week 4, the iothalamate infusion is repeated, and blood and urine samples are collected as at the beginning of the study. Patients then resume taking their ACE inhibitor or ARB once a day with the dose being increased at 2-week intervals. They come to NIH weekly after 1 week and then every other week for blood tests. Four weeks after reaching the highest FDA-recommended dose of medication tolerated, the iothalamate infusion and blood and urine collections are repeated. - Medication induction group: At the beginning of the study, patients have the iothalamate infusion and blood and urine collections described above and then begin to take either an ACE inhibitor or ARB. The dose is increased after 2 weeks. Patients monitor their blood pressure every day. After being on the highest dose for 4 weeks, patients repeat the iothalamate infusion and blood and urine collections. The study is then complete and they are provided a 2-month supply of medicine to take home. Information is gathered on symptoms, treatments, and results of past laboratory tests of all patients. Healthy volunteers provide blood and urine sample collections every month or every other month for up to four collections to be used for biomarker studies and the screen for common chronic diseases.

NCT ID: NCT00172276 Completed - Nephrotic Syndrome Clinical Trials

Angiotensin Converting Enzyme Gene Polymorphism in Children With Idiopathic Nephrotic Syndrome

Start date: n/a
Phase: N/A
Study type: Observational

Aims This study was conducted to examine the association between the ACE insertion/deletion (I/D) genotype distribution in children with idiopathic nephrotic syndrome and the response to steroid therapy. Patients and Methods The patients with idiopathic nephrotic syndrome were divided into 2 groups according to their clinical response to steroid: SS group including infrequent and frequent relapsers and non-SS group including steroid resistant (SR) and steroid dependent (SD) patients. Children without previous renal diseases and negative proteinuria were enrolled as control group in genetic study. The genotypes for ACE gene I/D polymorphism including DD, ID and II were analyzed by the newly developed automatic denaturing high performance liquid chromatography system (DHPLC).

NCT ID: NCT00065611 Completed - Nephrosis Clinical Trials

Steroid Treatment for Kidney Disease

Start date: July 2003
Phase: Phase 3
Study type: Interventional

Focal segmental glomerulosclerosis (FSGS) and minimal change disease are kidney diseases that are associated with increased excretion of protein in the urine. Approximately half of FSGS patients will lose kidney function within 8 years of diagnosis and will require dialysis. The purpose of this study is to determine whether intermittent oral steroid therapy can cause sustained remission of FSGS and MCD. Approximately 70 participants, including adults and children older than age 2, will be enrolled in this study. They will receive 48 doses of oral dexamethasone over a period of 48 weeks. One group will take two daily doses every 2 weeks; the other group will take four daily doses every 4 weeks. Doctors will monitor participants before, during, and after the steroid treatment with extensive exams and testing. At the completion of the study, researchers will evaluate the safety and efficacy of the drug treatment.

NCT ID: NCT00035334 Completed - Clinical trials for Rheumatoid Arthritis

Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis

Start date: October 2001
Phase: Phase 2/Phase 3
Study type: Interventional

The main objective of this study is to evaluate the safety and efficacy of NC-503 compared to placebo in patients with secondary (AA) amyloidosis using a composite assessment of clinical improvement/worsening of both renal and gastrointestinal functions.

NCT ID: NCT00004990 Completed - Nephrotic Syndrome Clinical Trials

Once-A-Month Steroid Treatment for Patients With Focal Segmental Glomerulosclerosis

Start date: March 2000
Phase: Phase 2
Study type: Interventional

This study will test the safety and effectiveness of a monthly dosing regimen of dexamethasone-a strong steroid medication-to treat patients with focal segmental glomerulosclerosis (FSGS). Patients with this disease have kidney fibrosis (scarring) and proteinuria (excessive excretion of protein in the urine) that, in about half of the patients eventually requires kidney dialysis or transplant. Currently, the most effective treatment for FSGS is high-dose steroids (prednisone) taken daily for 4 to 6 months. However, only about 30 percent of patients respond to this treatment, and it causes serious side effects in many patients. Other drugs, such as cyclosporin and cyclophosphamide, improve proteinuria in even fewer patients (about 10 percent) and also have serious side effects. This study will explore whether a monthly pulse dose of steroids will achieve disease remission with less toxicity. Adults and children with FSGS who: 1) have not received steroid treatment, or 2) could not tolerate daily steroid treatment, or 3) relapsed after conventional steroid treatment may be eligible for this study. Those enrolled will take dexamethasone by mouth for 4 days every 4 weeks for a total of 8 months. Patients will undergo various tests before treatment starts (baseline), during the course of treatment, and in follow-up visits to evaluate the effects of treatment as follows: 1. Review of kidney biopsy, medical evaluation, measurement of total daily urine protein excretion and kidney function, psychiatric testing for depression or other mood disorder 2. Measurements of blood pressure, blood chemistries and urine protein excretion - monthly during treatment 3. Questionnaire about the effects of treatment, if any, on mood and feelings - monthly during treatment 4. Photographs of the face and body (in underwear or shorts and tank top) to evaluate body fat distribution- baseline and 8 months 5. Eye examinations for cataracts and glaucoma - baseline and 8 months 6. Bone density scan (DEXA scan) of the lower spine and hip - baseline, 4 and 12 months 7. Magnetic resonance imaging (MRI) of the hips 8. Psychological evaluation and quality of life evaluation - baseline, 1, 2 and 8 months 9. Blood tests for adrenal gland function - baseline, 4 and 8 months 10. Blood and urine tests - 10, 12, 15, and 18 months Patients who achieve remission (whose urine protein levels decrease to normal) before completing the 8 months of dexamethasone will take one more dose and then stop therapy, but continue with follow-up. Patients who achieve remission but relapse may be offered a second course of treatment.