A Phase 4 interventional study of Sevelamer and Calcium carbonate in Degenerative Heart Valve Disease, Heart Valve Calcification and Chronic Kidney Disease(CKD), sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by China National Center for Cardiovascular Diseases · Phase 4, Interventional, and Treatment
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Among 20 studies testing sevelamer in Renal Insufficiency, Chronic — 1 open to participants now, 1 under way, none of them phase 3. Sevelamer · Renal Insufficiency, Chronic.
Among the 20 studies testing sevelamer in Renal Insufficiency, Chronic, this one is the 4th largest by planned enrollment, is the only one that started in 2024, is one of 3 in phase 4, and was the 20th registered.
3,095 studies on the registry are indexed under Renal Insufficiency, Chronic; 701 are open to participants now.
Browse Renal Insufficiency, Chronic studies →1 of the 20 studies testing sevelamer in Renal Insufficiency, Chronic is open now, in 1 country.
By country, each count listing its studies:
Sevelamer: first FDA approval 1998 (RENAGEL), first EMA approval 2000. What it is approved for, and how studies give it, is on its page →
Of the 435 Renal Insufficiency, Chronic studies recruiting now, 244 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 196 is above the median of 73 across 2,162 interventional studies indexed under Renal Insufficiency, Chronic.
Median enrollment 67 across the 20 interventional studies. Of the 18 that completed or were terminated, 4 (22%) have results posted.
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12 of 20 have an industry lead sponsor. The 10 most frequent:
China National Center for Cardiovascular Diseases is the lead sponsor of 270 studies on the registry; 142 are open to participants now.
China National Center for Cardiovascular Diseases has 1 study filed under Renal Insufficiency, Chronic — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies testing sevelamer in Renal Insufficiency, Chronic, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The goal of this clinical trial is to learn if calcium-phosphorus regulation therapy can slow the progression of heart valve calcification in patients with degenerative heart valve disease and chronic kidney disease (CKD). The main questions it aims to answer are:
Participants will:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥ 50 years old.
Degenerative valvular heart disease clearly diagnosed by ultrasound or clinical history with calcification manifestation (including no stenosis or insufficiency due to calcification, mild, moderate and severe stenosis and insufficiency caused by calcification).
\< 60 mL/min (CKD-EPI formula).
Exclusion Criteria:
Patients refuse to sign the form for the study.
Non-degenerative valvular heart disease even if there is valvular calcification, such as rheumatic valvular heart disease, congenital valvular heart disease, etc.
Valve lesions are evaluated by cardiac surgeons and have indications for surgical thoracotomy or interventional medical treatment and there are no surgical .
less than 1 year. ⑤ Abnormal parathyroid function.
Those with renal insufficiency who are planned to undergo dialysis treatment within half a year.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sevelamer is administered orally, and the administration strategy is implemented in accordance with the 2017 KDIGO Guideline and the 2019 Chinese Guideline for the Diagnosis and Treatment of Mineral and Bone Disorders in Chronic Kidney Disease.
Drug: Sevelamer
Calcium carbonate is administered orally, and the administration strategy is implemented in accordance with the 2017 KDIGO Guideline and the 2019 Chinese Guideline for the Diagnosis and Treatment of Mineral and Bone Disorders in Chronic Kidney Disease.
Drug: Calcium carbonate
Sevelamer is administered orally, and the administration strategy is implemented in accordance with the 2017 KDIGO Guideline and the 2019 Chinese Guidelines for the Diagnosis and Treatment of Mineral and Bone Disorders in Chronic Kidney Disease.
Calcium carbonate is administered orally, and the administration strategy is implemented in accordance with the 2017 KDIGO Guideline and the 2019 Chinese Guideline for the Diagnosis and Treatment of Mineral and Bone Disorders in Chronic Kidney Disease.
The change of valve calcification score on CT scan from baseline to 1 year of treatment.
The change of valve calcification score on CT scan from baseline to 1 year of treatment.
Time frame: from baseline to 1 year of treatment
major cardiovascular events
The composite endpoint of major cardiovascular events includes hospitalization or outpatient/emergency department visits due to heart failure; cardiovascular death; undergoing interventional/surgical valve surgery; and non-fatal myocardial infarction.
Time frame: from baseline to 1 year of treatment
Started Mar 2024 (actual). Primary completion is estimated for Jun 2025, 15 months after the start.
Of 100 non-industry phase 4 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 67. This study's planned 15 months is below that.
Counting every sponsor, half of 116 studies reached it within 43 months; a quarter within 22 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Sevelamer
Renal Insufficiency, Chronic →
China National Center for Cardiovascular Diseases →