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Generated: February 22, 2018

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CLINICAL TRIALS PROFILE FOR
INULIN

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Clinical Trial Listing

Trial ID Title Status Sponsor Phase Summary
NCT00005107 Role of Nitric Oxide in Cirrhosis: Relationship With Systemic Hemodynamics, Renal Function, Vasoactive Systems and EndotoxemiaUnknown statusNational Center for Research Resources (NCRR)Phase 1 This study is to determine whether a compound, nitric oxide, made within the body, is the factor responsible for the changes in blood pressure and renal (kidney) functions that may occur during the course of cirrhosis. Patients with cirrhosis (liver scarring which causes poor liver function) will be eligible to participate. A group of healthy subjects will also be studied to compare the effects of the treatment to patients with cirrhosis and to confirm safety. A total number of 30 patients with cirrhosis and 10 healthy subjects will be enrolled in the study.
NCT00240045 The Use of Drugs to Improve Kidney Function in Patients With Liver and Kidney DysfunctionCompletedNovartisPhase 2/Phase 3 We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are mediated in part by diminished circulatory volume and that treatment with midodrine, octreotide and albumin can improve renal and patient outcomes by restoring effective circulating volume and systemic perfusion. Our primary objective is to assess change in creatinine clearance using inulin. We will enroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion and exclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR, albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before, during, and after initiation of drug and compared.
NCT00240045 The Use of Drugs to Improve Kidney Function in Patients With Liver and Kidney DysfunctionCompletedUniversity of AlbertaPhase 2/Phase 3 We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are mediated in part by diminished circulatory volume and that treatment with midodrine, octreotide and albumin can improve renal and patient outcomes by restoring effective circulating volume and systemic perfusion. Our primary objective is to assess change in creatinine clearance using inulin. We will enroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion and exclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR, albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before, during, and after initiation of drug and compared.
NCT00275158 Glomerular Injury of PreeclampsiaCompletedNational Center for Research Resources (NCRR)N/A Pre-eclampsia complicates 7 - 10% of pregnancies and constitutes a leading cause of fetal growth retardation and premature birth, as well as infant and maternal morbidity and mortality. The kidney is the primary site of injury resulting in high blood pressure, loss of protein into the urine and decreased kidney function. The release of vasoconstrictors over vasodilators from an abnormal placenta may underlie pre-eclampsia. Nitric Oxide (NO) is an important vasodilator that is thought to play an important role in the kidneys ability to accommodate to a healthy pregnancy. Normal pregnancy in the rat is accompanied by increased production of NO and its second messenger cGMP. There is a parallel increase in renal expression of constitutive nitric oxide synthase (NOS), the enzyme that generates NO from arginine. In the pregnant rat, an infusion of NG-nitro-L-arginine methyl ester (L-NAME), an exogenous inhibitor of NOS, has been shown to replicate some of the hemodynamic features of the syndrome of pre-eclampsia. In a recent animal study, L-arginine supplementation reversed the adverse effects of L-NAME on pregnancy by attenuating the high blood pressure and by significantly decreasing protein loss in the urine. To date, studies of the use of L-arginine supplementation to treat women with pre-eclampsia have been small or uncontrolled and have only assessed blood pressure as a primary outcome measure. We report a single center, randomized, placebo-controlled trial of L-arginine supplementation for the treatment of pre-eclampsia, in which precise physiological techniques have been utilized to assess kidney dysfunction in addition to blood pressure.
NCT00275158 Glomerular Injury of PreeclampsiaCompletedNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)N/A Pre-eclampsia complicates 7 - 10% of pregnancies and constitutes a leading cause of fetal growth retardation and premature birth, as well as infant and maternal morbidity and mortality. The kidney is the primary site of injury resulting in high blood pressure, loss of protein into the urine and decreased kidney function. The release of vasoconstrictors over vasodilators from an abnormal placenta may underlie pre-eclampsia. Nitric Oxide (NO) is an important vasodilator that is thought to play an important role in the kidneys ability to accommodate to a healthy pregnancy. Normal pregnancy in the rat is accompanied by increased production of NO and its second messenger cGMP. There is a parallel increase in renal expression of constitutive nitric oxide synthase (NOS), the enzyme that generates NO from arginine. In the pregnant rat, an infusion of NG-nitro-L-arginine methyl ester (L-NAME), an exogenous inhibitor of NOS, has been shown to replicate some of the hemodynamic features of the syndrome of pre-eclampsia. In a recent animal study, L-arginine supplementation reversed the adverse effects of L-NAME on pregnancy by attenuating the high blood pressure and by significantly decreasing protein loss in the urine. To date, studies of the use of L-arginine supplementation to treat women with pre-eclampsia have been small or uncontrolled and have only assessed blood pressure as a primary outcome measure. We report a single center, randomized, placebo-controlled trial of L-arginine supplementation for the treatment of pre-eclampsia, in which precise physiological techniques have been utilized to assess kidney dysfunction in addition to blood pressure.
NCT00297401 Renal and Peripheral Hemodynamic Function in Patients With Type 1 Diabetes MellitusCompletedHeart and Stroke Foundation of CanadaPhase 3 Protein kinase C (PKC), an enzyme in the body, has been implicated in the process of diabetic microvascular complications. The purpose of this study will be to evaluate the renal hemodynamic and peripheral vascular effects of PKC inhibition with ruboxistaurin mesylate (an inhibitor of PKC) in patients with Type 1 diabetes mellitus and evidence of early nephropathy. In this pilot study, 21 patients with type 1 diabetes were planned to be randomized to LY333531 or placebo in a 2:1 fashion, after an initial period of testing. After 8 weeks of study drug, patients were retested.
NCT00297401 Renal and Peripheral Hemodynamic Function in Patients With Type 1 Diabetes MellitusCompletedChromaderm, Inc.Phase 3 Protein kinase C (PKC), an enzyme in the body, has been implicated in the process of diabetic microvascular complications. The purpose of this study will be to evaluate the renal hemodynamic and peripheral vascular effects of PKC inhibition with ruboxistaurin mesylate (an inhibitor of PKC) in patients with Type 1 diabetes mellitus and evidence of early nephropathy. In this pilot study, 21 patients with type 1 diabetes were planned to be randomized to LY333531 or placebo in a 2:1 fashion, after an initial period of testing. After 8 weeks of study drug, patients were retested.
NCT00305409 Synbiotic Treatment in Crohn's Disease PatientsCompletedUniversity of DundeeN/A The purpose of this study is to determine whether administration of a synbiotic, comprised on inulin and a bifidobacterial probiotic will colonise the gut wall and down-regulate TNF-alpha and other pro-inflammatory cytokines in the mucosa of Crohn's patients with active disease to reduce mucosal inflammation and induce remission.
NCT00309309 Metabolic and Renal Effects of Rosiglitazone in Kidney TransplantCompletedMario Negri Institute for Pharmacological ResearchPhase 2 Abnormalities in glucidic and lipidic metabolism are common features in renal transplant patients on chronic immunossupression with steroids and calcineurin inhibitors. In kidney transplant patients with chronic rejection these abnormalities cluster with renal and cardiovascular risk factors and altogether may sustain premature graft loss and may increase the risk of cardiovascular morbidity and mortality. Thiozolidinediones are a new class of oral antidiabetic agents that may increase insulin sensitivity improving the glucose tolerance and dyslipidemia. Moreover, rosiglitazone –one of these drugs- has been reported to decrease blood pressure and albuminuria in subjects with type 2 diabetes and nephropathy. Recent finding that glitazones ameliorate the glucidic and lipidic profile induced by steroid treatment in healthy subjects, provided a further rationale to evaluate the metabolic and renal effects of glitazones in renal transplant patients on chronic steroid therapy. Thus, we designed and organized a pilot study to assess the short-term risk/benefit profile of rosiglitazone in renal transplant patients with chronic rejection. Ten patients will have a basal evaluation of insulin sensitivity, glucose tolerance,lipid profile, renal hemodynamic and albuminuria. These evaluations will be repeated at the end of the treatment (4 months of therapy with rosiglitazone 8 mg/day) period and 2 months after treatment withdrawal.
NCT00319007 Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous PolyposisUnknown statusDutch Cancer SocietyPhase 2 The purpose of this study is to determine whether sulindac and VSL#3 - inulin, either combined or alone, are effective in treating or preventing adenoma development in the ileal anal pouch in patients with familial adenomatous polyposis.
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Conditions

Condition Name

Condition Name for inulin
Intervention Trials
Chronic Kidney Disease 4
Obesity-induced Hyperfiltration 2
Healthy 2
Metabolic Syndrome 2
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Condition MeSH

Condition MeSH for inulin
Intervention Trials
Kidney Diseases 8
Renal Insufficiency, Chronic 4
Diabetes Mellitus 4
Diabetes Mellitus, Type 1 3
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Trial Locations

Trials by Country

Trials by Country for inulin
Location Trials
United States 8
United Kingdom 4
Canada 3
Switzerland 3
Italy 2
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Trials by US State

Trials by US State for inulin
Location Trials
District of Columbia 2
California 1
Colorado 1
Washington 1
New York 1
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Clinical Trial Progress

Clinical Trial Phase

Clinical Trial Phase for inulin
Clinical Trial Phase Trials
Phase 4 5
Phase 3 5
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for inulin
Clinical Trial Phase Trials
Completed 20
Recruiting 5
Unknown status 4
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Clinical Trial Sponsors

Sponsor Name

Sponsor Name for inulin
Sponsor Trials
National Center for Research Resources (NCRR) 2
University of Edinburgh 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 2
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Sponsor Type

Sponsor Type for inulin
Sponsor Trials
Other 34
NIH 5
Industry 5
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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Queensland Health
Healthtrust
Medtronic
Federal Trade Commission
Dow
Argus Health
Covington
QuintilesIMS
Baxter

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