Sucroferric oxyhydroxide (trade name: Velphoro) has been approved in Germany since August 2014 for treating chronic kidney disease in adults by regulating phosphate levels. It is an option for patients who have hemodialysis or peritoneal dialysis and is designed to be combined with other drugs to prevent secondary diseases caused by renal insufficiency such as bone fractures.
Kidney disease makes it difficult to eliminate metabolic waste products, and they end up accumulating in the body. Chronic kidney disease develops gradually and may eventually cause end-stage kidney failure. Dialysis is needed if the kidneys have stopped working. Dialysis is used to clean the blood – meaning that it can help to replace all or most of what the kidneys do. Hemodialysis involves a machine called a dialyzer that filters waste products from the blood outside of the body and then returns the filtered blood. Peritoneal dialysis cleanses the blood inside the body through the perineum.
Kidney disease causes the kidney to lose its ability to regulate the body’s salt, water and acid–base levels. When that happens, phosphate can accumulate in the bloodstream, a condition called hyperphosphatemia. Phosphate binders can bind the phosphate from food before it reaches the blood circulatory system to help prevent complications such as cardiovascular disease or higher bone fracture risk.
Sucroferric oxyhydroxide is another phosphate binder that has been approved for treating hyperphosphatemia in people with chronic kidney disease who need dialysis. The drug does not have any calcium in it, so it is an option for people who are not able to take medication containing calcium.
Sucroferric oxyhydroxide is available as chewable tablets that are taken with meals. One tablet contains 500 mg of iron.
Treatment starts with 1500 milligrams of iron (three tablets) per day. Every two to four weeks the dose can be adjusted up or down by one tablet to reach an adequate serum phosphate level. This serum phosphate level is monitored regularly. Six tablets (3000 mg) is the maximum daily dose.
At the end of 2014, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) has examined whether sucroferric oxyhydroxide offers an added benefit to people with chronic kidney disease and hyperphosphatemia. Studies involving the following patient groups of were needed for comparison:
- People who can take phosphate binders that contain calcium (as monotherapy or in combination): Sucroferroc oxyhydroxide was to be compared with sevelamer or lanthanum carbonate
- People who cannot take phosphate binders containing calcium: Sucroferric oxyhydroxide was to be compared compared with sevelamer or lanthanum carbonate.
The manufacturer did provide not any data suitable for comparisons in either group, so it is still not clear whether sucroferric oxyhydroxide advantages or disadvantages compared to the respective standard therapy.
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the "early benefit assessment of medications." On the basis of this review and the hearings received, G-BA passed a resolution on the added benefit of sucroferric oxyhydroxide (Velphoro).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Sucroferric oxyhydroxide - Benefit assessment according to §35a Social Code Book V. Dossier assessment A14-37. Cologne: IQWiG. January 2, 2014.
IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.
Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. We do not offer individual consultations.
Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.