Phosphorus Control: New Hope for Dialysis Patients?

observational-study PMID: 37473746

Quick Summary: A new study found that a medication called sucroferric oxyhydroxide (SFOH) is just as good as a common drug (sevelamer carbonate) at lowering high phosphorus levels in Chinese dialysis patients. Plus, patients taking SFOH needed to take fewer pills!

What The Research Found

This study looked at how well two different medicines control high phosphorus levels in people on dialysis. High phosphorus is a common problem for people with kidney disease. The study compared sucroferric oxyhydroxide (SFOH) to sevelamer carbonate, a medicine often used for this purpose.

Here's what they found:

SFOH worked just as well as sevelamer carbonate at lowering phosphorus levels in the blood.

More people reached their target phosphorus levels faster with SFOH.

Patients taking SFOH needed to take fewer pills each day.

Both medicines were generally safe, but SFOH was linked to more stomach issues like diarrhea.

Study Details

Who was studied: 286 Chinese adults on dialysis with high phosphorus levels.

How long: The study lasted 12 weeks.

What they took: Patients were given either SFOH or sevelamer carbonate. The dose was adjusted over the first 8 weeks, and then kept the same for the last 4 weeks.

What This Means For You

If you're a Chinese dialysis patient with high phosphorus, this study suggests:

SFOH could be a good option to help control your phosphorus levels.

You might need to take fewer pills with SFOH, which could make it easier to stick to your treatment.

Talk to your doctor about whether SFOH is right for you. They can help you weigh the benefits and risks, especially if you have a history of stomach problems.

Study Limitations

It's important to remember:

The study was only done on Chinese patients, so the results might not be the same for everyone.

The study was relatively short (12 weeks), so we don't know the long-term effects of SFOH.

Because the study wasn't "blinded" (meaning the doctors and patients knew which medicine they were taking), there could be some bias in the results.

The dose of the medication was adjusted during the study, which might not reflect how people take the medication in the real world.

Key Findings

This 12-week phase III trial demonstrated that sucroferric oxyhydroxide (SFOH) was non-inferior to sevelamer carbonate in lowering serum phosphorus (sP) in Chinese dialysis patients with hyperphosphataemia. SFOH achieved a mean sP reduction of -0.71 mmol/L (SD 0.60) compared to -0.63 mmol/L (SD 0.52) with sevelamer (difference: 0.08 mmol/L; 95% CI -0.02 to 0.18). SFOH also enabled faster attainment of target sP (1.13–1.78 mmol/L) at week 4 (56.5% vs. 32.8% for sevelamer) and required a lower daily pill burden (3.7 vs. 9.1 tablets/day during maintenance). Safety profiles were comparable, though SFOH had higher rates of gastrointestinal adverse events (e.g., diarrhea).

Study Design

Type: Randomized, open-label, active-controlled, parallel-group, multicenter phase III trial.
Population: 286 Chinese adults (≥18 years) undergoing dialysis with baseline sP >1.78 mmol/L.
Duration: 12 weeks (8-week dose titration + 4-week maintenance).
Comparator: Sevelamer carbonate, a standard phosphate binder.

Dosage & Administration

SFOH: Initiated at 1,500 mg iron/day (3 tablets of 500 mg iron each).
Sevelamer: Initiated at 2.4 g/day (8 tablets of 300 mg each).
Doses were adjusted during the 8-week titration phase based on sP levels, with fixed maintenance doses for the final 4 weeks.

Results & Efficacy

Primary endpoint: Non-inferiority confirmed; the lower limit of the 95% CI (-0.02 mmol/L) exceeded the pre-specified margin (-0.34 mmol/L).
Secondary endpoints:
Week 4 target sP attainment: 56.5% (SFOH) vs. 32.8% (sevelamer).
Maintenance phase pill burden: 3.7 tablets/day (SFOH) vs. 9.1 tablets/day (sevelamer).
Safety: Adverse events occurred in 60.6% (SFOH) and 67.4% (sevelamer) of patients, with no new safety signals. Gastrointestinal events (e.g., diarrhea) were more frequent with SFOH.

Limitations

Open-label design: Potential for bias due to lack of blinding.
Short duration: 12 weeks may not capture long-term efficacy or safety.
Ethnic specificity: Results limited to Chinese dialysis patients; generalizability to other populations uncertain.
Dose titration: Adjustments during the study may not reflect real-world adherence or fixed-dosing scenarios.

Clinical Relevance

For Chinese dialysis patients with hyperphosphataemia, SFOH offers a viable alternative to sevelamer with comparable phosphorus-lowering efficacy and a significantly reduced pill burden, which could improve treatment adherence. However, clinicians should monitor for gastrointestinal side effects. The study supports SFOH’s benefit-risk profile in this population but highlights the need for longer-term and broader demographic research.

Source: PubMed (NCT03644264) | Date: 2024