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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 it to look at how effective and safe Magnesium iron hydroxycarbonate is in controlling levels of phosphate in the blood in patients who receive hemodialysis.
High levels of phosphate in the blood are linked with serious effects, due to calcium imbalances (high levels of parathyroid hormone (PTH), bone disease, formation of calcium deposits in the body, and blood-vessel disease).
Current guidelines indicate that blood phosphorus levels should be maintained between 1.13 to 1.78 mmol/L in patients who receive hemodialysis.
This study is designed to investigate magnesium iron hydroxycarbonate's ability to lower and control patients' blood phosphate to the recommended levels and compare the average blood phosphate, calcium, calcium-phosphate product, PTH and magnesium concentrations and overall safety with placebo (or "dummy") tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermagate | Drug | Film coated tablet 500mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Roe, MB ChB | Nottingham Renal and Transplant Unit, Nottingham City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1614 West 42nd Street | Pine Bluff | Arkansas | 71603 | United States | ||
| US Renal Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. |
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| Placebo | Drug | Oral administration, film coated tablet, 0mg |
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C541219 | iron-magnesium hydroxycarbonate |
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