A Phase 4 interventional study of Sevelamer Hydrochloride and Lanthanum Carbonate in Chronic Kidney Disease, sponsored by Medical University of Lodz. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-27.
Sponsored by Medical University of Lodz · 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 14th largest by enrollment, is the only one that started in 2018, is one of 3 in phase 4, and was the 19th 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. Recruiting first, the newest first:
China National Center for Cardiovascular Diseases · Sites in China
Ages 50+
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: 18 Years and older · all sexes · no healthy volunteers.
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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 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 34 is below 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:
Medical University of Lodz is the lead sponsor of 107 studies on the registry; 10 are open to participants now.
Medical University of Lodz has 5 studies 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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Sevelamer hydrochloride (SE) can increase intestinal calcium absorption in contrast to lanthanum carbonate (LA). Study compared effect of LA and SE on serum and urine phosphate and calcium, and hormones regulating mineral-bone metabolism.
Recent experimental studies have shown that a non-calcium based phosphate binder sevelamer hydrochloride can increase intestinal calcium absorption in contrast to lanthanum carbonate. It is unknown whether such the difference may have an effect on bone metabolism and/or modify the development of vascular calcification in patients with chronic kidney disease. The aim of the study was to compare the effect of a single dose of 1000 mg of lanthanum carbonate with 2,4 mg of sevelamer hydrochloride on serum and urine calcium following an oral load of 5 g of calcium carbonate given with a meal with standardized phosphate content.
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.
Exclusion Criteria:
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the subject receive a single dose of 2,4 g
Drug: Sevelamer Hydrochloride · Drug: Lanthanum Carbonate
the subject receive a single dose of 1.0 g
Drug: Sevelamer Hydrochloride · Drug: Lanthanum Carbonate
Single oral doses of lanthanum (1000 mg) or Sevelamer (2400 mg) were administered in random order 15 minutes after 5 g calcium carbonate with standardized meal
Also known as: Renagel
Single oral doses of lanthanum (1000 mg)
Also known as: Fosrenol
the change of serum calcium for 24 hours after each drug
absolute change vs baseline and 24h area under the curve
Time frame: 3, 6, 12 and 24 hours after administration of each drug
Plan to share: No
Ran from Mar 2018 to primary completion in Dec 2020, 33 months.
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 33 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.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sevelamer · Lanthanum carbonate
Renal Insufficiency, Chronic →