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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT00773513 Completed - Clinical trials for Chronic Renal Anemia

A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

Start date: December 12, 2008
Phase: Phase 4
Study type: Interventional

This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.

NCT ID: NCT00773409 Completed - Renal Insufficiency Clinical Trials

Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)

Start date: October 2008
Phase: N/A
Study type: Observational

The objective of this long term study is to prospectively evaluate the incidence of NSF in patients with severe CKD or kidney failure including patients undergoing dialysis (stages 4 and 5 i.e., with an eGFR below 30)who have not had exposure to a GBCA within 10 years prior to enrollment.

NCT ID: NCT00772772 Completed - Clinical trials for Chronic Kidney Disease

Vitamin D Repletion in Chronic Kidney Disease

Start date: March 2008
Phase: Phase 0
Study type: Interventional

The reason for doing this research is that people with kidney disease often suffer from heart disease. Why this happens is not fully known. A possible cause may be high blood levels of a substance made by bacteria called "endotoxin". The blood levels of this substance are high in people with medium-level kidney disease. We want to know if replacing normal amounts of Vitamin D can help lower the levels of this substance. We also want to know if replacing normal amounts of Vitamin D is associated with other changes that may help heart disease. We hope that our research will help figure out if levels of this substance can be lowered by replacing normal amounts of Vitamin D. Normal subjects are enrolled to have a 'control' set for comparison purposes.

NCT ID: NCT00772382 Completed - Clinical trials for Chronic Kidney Disease

Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

Start date: December 2008
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia. The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.

NCT ID: NCT00769834 Withdrawn - Clinical trials for Chronic Kidney Disease

Disc Edema in Patients With Chronic Kidney Disease

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

Papilledema is defined as swelling of the optic nerves often due to increased intracranial pressure. When present, it often indicates life-threatening lesions of the brain such as tumors, abscesses, meningitis, encephalitis, venous sinus obstruction or intracranial hemorrhage. A similar clinical picture can also be caused by other conditions such as malignant hypertension, diabetic papillopathy and uremia. When the intracranial pressure is elevated in the absence of any known cause then it is called Idiopathic Intracranial Hypertension (IIH). Untreated papilledema can cause progressive optic nerve damage and blindness. Patients with chronic kidney disease have a number of co-morbidities and thus are at an increased risk for developing papilledema. Although clinicians have observed that patients with kidney diseases have increased incidence of papilledema (unpublished data by Corbett et al), there have been no studies on this subject to date. We believe that a higher incidence of papilledema is found in patients with kidney diseases and this study could provide evidence to suggest routine ophthalmic screening in this patient group. Hypothesis: The prevalence of optic disc swelling is increased in patients with chronic kidney disease. Purpose: To establish the prevalence of disc edema in patients with chronic kidney disease.

NCT ID: NCT00768638 Completed - Clinical trials for Chronic Kidney Disease

Study of Atorvastatin Dose Dependent Reduction of Proteinuria

SARP
Start date: October 2008
Phase: Phase 4
Study type: Interventional

Randomized controlled double blind study of parallel groups to evaluate the comparative effects of low-dose of atorvastatin on proteinuria in patients with stage 3 or 4 chronic kidney disease.

NCT ID: NCT00767897 Completed - Clinical trials for Chronic Kidney Disease

The Impact of the Human Papilloma Virus in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients

Start date: November 2011
Phase:
Study type: Observational

The proposed study is a pilot study and a first step towards developing an optimized HPV vaccination strategy for girls who have CKD, or are on dialysis or have a kidney transplant.

NCT ID: NCT00764816 Completed - Clinical trials for Chronic Kidney Disease

Effect of Dietary Protein Source on Phosphaturia, PTH and FGF23 in Patients With CKD 3 and 4

Start date: October 2008
Phase: N/A
Study type: Interventional

Phosphorus is a substance in the blood that comes from food and is normally cleared from the body by the kidneys. In patients with kidney disease, excess phosphorus may build up in the body as you eat. This leads to problems with bones and blood vessels over time. In this study, we will compare the blood and urine before and after eating one week of a diet with a protein from plants (soy and grains) and before and after another one week of diet with protein from animals (meat and dairy products). The amount of phosphorus that the kidney puts out in the urine, and the changes in blood hormones in response to the diet will be measured at the beginning and end of each week on the two diets.

NCT ID: NCT00761657 Completed - Anemia Clinical Trials

Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis

Start date: November 1, 2006
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to participants with chronic kidney disease (CKD) not requiring dialysis.

NCT ID: NCT00758537 Completed - Clinical trials for Chronic Kidney Disease

Tryptophan Metabolism in Kidney Disease

Start date: January 2007
Phase: N/A
Study type: Observational

Tryptophan metabolism in kidney disease will be investigated in patients with chronic kidney disease stages (ADOQI 3-5). Tryptophan levels and respective catabolites will be assessed under hemodialysis.