2 List of all research recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future.

2.1 Phosphate binders in adults with CKD stage 4 or 5

Which binders are most effective in controlling serum phosphate in adults with stage 4 or 5 CKD who are not on dialysis?

Why this is important

Limited evidence was found on the use of phosphate binders in adults with stage 4 or 5 CKD. While it is possible in some instances to extrapolate from the evidence on people with stage 5 CKD who are on dialysis, it is not ideal. Therefore, a series of RCTs should be conducted to examine the comparative effectiveness of various phosphate binders against each other for the management of serum phosphate in adults with stage 4 or 5 CKD. These trials should examine the long-term (ideally 12-month) effects of the various binders on outcomes such as serum phosphate, serum calcium, adverse events and the ability of the binders to control serum phosphate and calcium within the given ranges.

2.2 Effectiveness and safety of aluminium hydroxide in adults

In adults with stage 4 or 5 CKD, including those on dialysis, what is the long-term effectiveness and safety of aluminium hydroxide in controlling serum phosphate?

Why this is important

Limited evidence was found on the efficacy of aluminium hydroxide in adults and no evidence was found on the long-term efficacy and safety of aluminium hydroxide. A series of RCTs should be conducted separately in adults with stages 4 or 5 CKD who are not on dialysis and those with stage 5 who are on dialysis. These trials should be run for a minimum of 12 months and should examine the effect of aluminium hydroxide on outcomes such as serum phosphate, serum calcium, adverse events and the ability of the binders to control serum phosphate and calcium within the given ranges. In addition, specific data should be collected on aspects relating to aluminium toxicity.

2.3 Effectiveness and safety of magnesium carbonate in adults

In adults with stage 4 or 5 CKD, including those on dialysis, what is the long-term effectiveness and safety of magnesium carbonate in controlling serum phosphate?

Why this is important

Limited evidence was found on the use of magnesium carbonate to control serum phosphate. However, the evidence that was assessed suggested that magnesium carbonate could be very effective in controlling serum phosphate. A series of RCTs should be conducted separately in adults with stages 4 or 5 CKD who are not on dialysis and those with stage 5 who are on dialysis. These trials should be run for a minimum of 12 months and should examine the effect of magnesium carbonate on outcomes such as serum phosphate, serum calcium, adverse events and the ability of the binders to control serum phosphate and calcium within the given ranges. In addition, specific data should be collected on aspects relating to magnesium toxicity.

2.4 Phosphate binders in children

Which binders are most effective in controlling serum phosphate in children with stage 4 or 5 CKD, including those who are on dialysis?

Why this is important

Limited evidence was found on the use of phosphate binders in children with stage 5 CKD who are on dialysis, and none was found for those with stage 4 or 5 CKD who are not on dialysis. Therefore, a series of RCTs should be conducted that examine the comparative effectiveness of various phosphate binders against each other for the management of serum phosphate. These RCTs should be conducted separately in those with stages 4 or 5 CKD who are not on dialysis and those with stage 5 who are on dialysis. These trials should examine the long-term (ideally 12-month) effects of the various binders on outcomes such as serum phosphate, serum calcium, adverse events and the ability of the binders to control serum phosphate and calcium within the given ranges, as well as the most appropriate sequencing of binders.

2.5 Sequencing and combining of phosphate binders in adults

For adults with stage 4 or 5 CKD, including those on dialysis, what is the most effective sequence or combination of phosphate binders to control serum phosphate?

Why this is important

It is thought that the longer people remain on calcium-based binders, the greater their risk of developing hypercalcaemia. However, no evidence was found on the most appropriate sequence or combination of phosphate binders a person should receive to control serum phosphate and serum calcium. A series of RCTs should be conducted separately in adults with stages 4 or 5 CKD who are not on dialysis and those with stage 5 who are on dialysis. These trials should be run for a minimum of 12 months and should examine comparative effectiveness of various sequences and combinations of available phosphate binders on outcomes such as serum phosphate, serum calcium, adverse events and the ability of the binders to control serum phosphate and calcium within the given ranges.

  • National Institute for Health and Care Excellence (NICE)