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Can a common phosphate binder tame kidney disease hormones?

NCT ID NCT01220843

Disease control Sponsor: Centre Hospitalier Universitaire, Amiens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether sevelamer carbonate, a drug that binds phosphate in the gut, can lower levels of a hormone called FGF-23 in people with chronic kidney disease (CKD) who are not yet on dialysis. The trial included 98 adults with moderate to severe CKD and high FGF-23 levels. Participants took either sevelamer carbonate or a placebo for 12 weeks, and researchers measured changes in FGF-23 and other mineral metabolism markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sevelamer carbonate (Renvela 800)
What this could lead to
If successful, this could help manage mineral metabolism in chronic kidney disease and potentially slow disease progression.
What could go wrong
This is a small, completed Phase 3 trial with 98 participants. Results may not apply to all CKD patients, and the drug only targets a specific marker, not the disease itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

98 people

The number who actually took part.

Start date

Oct 2010

Finished

Apr 2013

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients who gave their written consent * Women or men over 18 years * No concomitant treatment with phosphate binders * CKD patients not on dialysis stage 3b or 4, as a GFR (glomerular filtration rate) between 15 and 45 ml/min/1.73m2, using simplified MDRD formula * At the inclusion visit,patients with blood results as levels of C-terminal FGF-23 \> 120 rU/ml and fasting phosphatemia \> 1.0 mmol/l * Able to comply with the study procedures during all the study period * Willing to abstain from taking any following medication during all the study period :antiacid and phosphate binders with aluminium, magnesium, calcium or lanthanum;Treatment for hyperparathyroid : active vitamin D and calcimimetic ; native vitamin D * Female subjects who are of childbearing potential must have a reliable contraceptive methods during all the study period (hormonal, barrier methods or intrauterine device) * No Participation in any clinical trial using an investigational product or device during the 30 days preceding the first protocol visit * Informed patient who agreed with the utilisation of his data for the study * Able to read and understand french and study objectives * Inscription to medical assurance Exclusion Criteria: * predisposition with or presence of intestinal or ileus obstruction or severe gastrointestinal motility disorder(like severe constipation) * Antecedent of major gastrointestinal surgery * Abusive consumption of alcohol and drug (exclude tabacco) according the investigator * Arrythmia treated by antiarrythmic agent or epilepsia treated by anticonvulsant * Antecedent of kidney transplantation * Antecedent of parathyroidectomy * At the inclusion visit,patients with blood results as fasting phosphatemia \> 1.78 mmol/l or serum 25(OH)D3\< 20 ng/ml (\<50 nmol/) * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic renal failure

Contacts and locations

Locations

  • CH Valenciennes hémodialyse

    Valenciennes, 59322, France

  • CHU Amiens service de nephrologie

    Amiens, 8000, France

  • CHU Caen service de néphrologie

    Caen, 14033, France

  • CHU Lyon service de néphrologie

    Lyon, 69437, France

  • CHU Marseille Service de néphrologie

    Marseille, 13385, France

  • CHU Reims service de néphrologie

    Reims, 51092, France

  • CHU St Etienne Hopital Nord Service de néphrologie

    Saint-Etienne, 42055, France

  • CHU de Bordeaux Service de néphrologie

    Bordeaux, 33076, France

  • CHU de Montpellier Hôpital Lapeyronie Service de Néphrologie

    Montpellier, 34295, France

  • CHU de Nancy service de néphrologie

    Vandeuvre Les Nancy, 54511, France

  • CHU de Nice Service de néphrologie

    Nice, 06002, France

  • Clinique du Landy Centre de dialyse

    Saint-Ouen, 93400, France

  • Hôpital Européen Georges Pompidou Service de Nephrologie

    Paris, 75098, France

  • Hôpital Tenon Service de Nephrologie

    Paris, 75020, France

  • Néphrologie - Dialyse Centre de Rein Artificiel

    Tassin-la-Demi-Lune, 69160, France

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