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Hyperphosphatemia clinical trials

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NCT ID: NCT03409757 Terminated - Hyperphosphatemia Clinical Trials

Velphoro and Impact on the Oral Cavity and Gut Microbiome

MicrobiomEisen
Start date: February 28, 2018
Phase:
Study type: Observational

This pilot study will be carried out to determine if the regular intake of iron-based Velphoro® by hyperphosphatemia patients influences the microbiome in the oral cavity and/or the gut.

NCT ID: NCT02688764 Terminated - Hyperphosphatemia Clinical Trials

A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia

Start date: May 26, 2016
Phase: Phase 3
Study type: Interventional

This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3 clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and adolescent patients with CKD, and to provide safety and dosing information for this patient population. The Phoslyra (comparator) group provides information for a descriptive comparison of PA21 against a commonly used calcium-based phosphate binder (calcium acetate).

NCT ID: NCT02661295 Terminated - Clinical trials for End Stage Renal Disease

A Study of Ferric Citrate to Improve Inflammation and Lipid Levels

Start date: July 2015
Phase: Phase 4
Study type: Interventional

The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.

NCT ID: NCT01818687 Terminated - Clinical trials for Chronic Kidney Disease

Safety and Tolerability Study of MCI-196

Start date: August 2013
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the safety and tolerability of colestilan (MCI-196) in paediatric subjects (aged 2 years to <18 years) with CKD stages 3b to 5, diagnosed with hyperphosphataemia, who are not on dialysis.

NCT ID: NCT01814917 Terminated - Clinical trials for Chronic Kidney Disease

Long-term Extension Study of MCI-196

Start date: August 2013
Phase: Phase 3
Study type: Interventional

The Primary Objectives of this study are to assess the long-term efficacy of treatment with colestilan (MCI-196) (including combination therapy) and to assess the long-term safety of treatment with colestilan (MCI-196) (including combination therapy).

NCT ID: NCT01814904 Terminated - Clinical trials for Chronic Kidney Disease

Dose-finding Study of MCI-196

Start date: April 2014
Phase: Phase 3
Study type: Interventional

The Primary Objective of this study is to determine the initial starting doses of colestilan (MCI-196) in paediatric subjects with Chronic Kidney Disease Stage 5 on Dialysis and with Hyperphosphataemia.

NCT ID: NCT01725113 Terminated - Kidney Failure Clinical Trials

Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol

ECRIP
Start date: November 2012
Phase: Phase 4
Study type: Interventional

The purpose of this non-inferiority study is to compare the safety and effectiveness of a mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO) parathyroid hormone targets.

NCT ID: NCT00844662 Terminated - Clinical trials for Chronic Kidney Failure

Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride

Start date: July 2009
Phase: Phase 3
Study type: Interventional

Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb. The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring haemodialysis, compared with a marketed phosphate binder, sevelamer hydrochloride.

NCT ID: NCT00841126 Terminated - Clinical trials for Chronic Kidney Failure

Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate

Start date: July 2009
Phase: Phase 3
Study type: Interventional

Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb. The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring hemodialysis, compared with a marketed phosphate binder, lanthanum carbonate and placebo.

NCT ID: NCT00833768 Terminated - Clinical trials for Chronic Kidney Disease

A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis

ASPIRE
Start date: January 2009
Phase: Phase 3
Study type: Interventional

Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.