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Clinical Trial Details

Trial ID: L0958
Source ID: NCT00317694
Associated Drug: Fermagate
Title: Efficacy and Safety Study of Magnesium Iron Hydroxycarbonate for the Reduction of High Blood Phosphate in Hemodialysis Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Failure
Interventions: DRUG: Fermagate|DRUG: Placebo
Outcome Measures: Primary: Proportion of subjects who achieve controlled serum phosphate concentrations during the double-blind comparative phase, Mean of last two serum phosphate values in the double blind phase | Secondary: Change from baseline in mean serum phosphate concentration, Mean of last two serum phosphate values|Change from baseline in serum calcium, Specified visits throughout the study period|Change from baseline calcium-phosphate product, Specified visits throughout the study period|Change from baseline PTH, Specified visits throughout the study period|Change from baseline magnesium, Specified visits throughout the study period|Assessment of adverse events, Throughout the study period|Assessment of routine safety laboratory parameters, Specified visits throughout the study period|Assessment of physical examination, At screen and follow-up|Assessment of 12-lead electrocardiogram, At screen and follow-up|Assessment of bowel habits, Specified visits throughout the study period
Sponsor/Collaborators: Sponsor: Ineos Healthcare Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 111
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-03
Completion Date: 2007-06
Results First Posted:
Last Update Posted: 2009-08-10
Locations: 1614 West 42nd Street, Pine Bluff, Arkansas, 71603, United States|US Renal Care, Stuttgart, Arkansas, 72160, United States|Davita Dialysis Center, Charlotte, North Carolina, 28208, United States|Southeast Renal Associates, Charlotte, North Carolina, 28208, United States|Renal Unit, Birmingham Heartlands Hospital, Birmingham, B9 5SS, United Kingdom|St Lukes Hospital, Bradford, BD5 0NA, United Kingdom|Richard Bright Renal Unit, Southmead Hospital, Bristol, BS10 5NB, United Kingdom|Addenbrookes Dialysis Centre, Addenbrookes Hospital, Cambridge, CB2 2QQ, United Kingdom|Renal Unit, Leicester General Hospital, Leicester, LE5 4PW, United Kingdom|Dialysis Unit, Broad Green Hospital, Liverpool, L14 3LB, United Kingdom|Royal Liverpool University Hospital, Liverpool, L7 8XP, United Kingdom|General Medicine and Nephrology, Norfolk and Norwich University Hospital, Norwich, NR4 7RF, United Kingdom|Nottingham Renal and Transplant Unit, Nottingham City Hospital, Nottingham, NG5 1PB, United Kingdom|Sheffield Kidney Unit, Northern General Hospital, Sheffield, S5 7AU, United Kingdom|Dept. of Nephrology, Morriston Hospital, Swansea, SA6 6NL, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00317694

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress