Chronic Kidney DiseasePhase 4NCT03451019
Different Effects of Non-calcium Phosphate Binders on Serum Calcium
A Phase 4 study testing Sevelamer Hydrochloride and Lanthanum Carbonate in people with Chronic Kidney Disease, run by Medical University of Lodz at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Sevelamer Hydrochloride and Lanthanum Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2018to 30 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patient
- with eGFR ≤45 ml/min
Who cannot join
- hypercalcemia (>ULN),
- serum phosphate >1.2 times normal value
- calcium-phosphate disturbances not associated with CKD, e.g. Paget disease, osteoporosis, any bone fracture within 6 months before study, multiple myeloma or any neoplastic disease, liver or biliary tract disease, primary hyperparathyroidism
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Nephrology, Hypertension and Kidney Transplantation
Lodz, 90-153
About this study
Official title: Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Gastrointestinal Calcium Absorption in Patients With Moderate to Advanced Chronic Kidney Disease
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Sevelamer Hydrochloride, Lanthanum Carbonate
- Keywords
- chronic kidney disease - mineral bone disorder, phosphate-binders
- Medical subject headings
- Renal Insufficiency, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevelamer HydrochlorideDrug
Also called Renagel
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
Lanthanum CarbonateDrug
Also called Fosrenol
Single oral doses of lanthanum (1000 mg)
| Study group | Role | What they receive |
|---|---|---|
| sevelamer hydrochloride | Active comparator | the subject receive a single dose of 2,4 g Receives: Drug: Sevelamer Hydrochloride; Drug: Lanthanum Carbonate |
| lanthanum carbonate | Active comparator | the subject receive a single dose of 1.0 g Receives: Drug: Sevelamer Hydrochloride; Drug: Lanthanum Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of serum calcium for 24 hours after each drug
absolute change vs baseline and 24h area under the curve
Measured: 3, 6, 12 and 24 hours after administration of each drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Mar 2018
- Primary completion15 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective randomized open-label study included 34 patients with CKD. Single oral dose of one of phosphate binders (sevelamer or lanthanum) were administered in random order 15 minutes after 5 g calcium carbonate with standardized meal. Serum calcium, phosphate and parathormone were measured at 0, 3, 6, 12, 24 hours after each medication. Bone alkaline phosphatase (BAP), sclerostin, calcitriol and FGF-23 were measured at 0, 12 and 24 hours after dose. Calcium and phosphate were measured in 24h urine collections after each drug.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, Michal Nowicki, Medical University of Lodz
- Investigators
- Michal Nowicki, Prof.MD PhD, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451019
- Sponsor's protocol ID
- S-L2018
- Status last verified
- Jul 2021
- First submitted
- 20 Feb 2018
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Makowka A, Nowicki M. Different Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Calcium Balance in Patients with Moderate to Advanced Chronic Kidney Disease. Ther Clin Risk Manag. 2021 Nov 2;17:1145-1151. doi: 10.2147/TCRM.S330649. eCollection 2021.
PubMed 34754193
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Gastrointestinal Calcium Absorption in Patients With Moderate to Advanced Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03451019
- Acronym / sponsor ID
- S-L2018
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease - mineral bone disorder, phosphate-binders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Collaborators
- Shire
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized open-label study included 34 patients with CKD. Single oral dose of one of phosphate binders (sevelamer or lanthanum) were administered in random order 15 minutes after 5 g calcium carbonate with standardized meal. Serum calcium, phosphate and parathormone were measured at 0, 3, 6, 12, 24 hours after each medication. Bone alkaline phosphatase (BAP), sclerostin, calcitriol and FGF-23 were measured at 0, 12 and 24 hours after dose. Calcium and phosphate were measured in 24h urine collections after each drug.
| Arm | Type | Receives |
|---|---|---|
| sevelamer hydrochloride | Active comparator | Drug: Sevelamer Hydrochloride, Drug: Lanthanum Carbonatethe subject receive a single dose of 2,4 g |
| lanthanum carbonate | Active comparator | Drug: Sevelamer Hydrochloride, Drug: Lanthanum Carbonatethe subject receive a single dose of 1.0 g |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patient
- with eGFR ≤45 ml/min
Key exclusion criteria (3 listed)
- hypercalcemia (>ULN),
- serum phosphate >1.2 times normal value
- calcium-phosphate disturbances not associated with CKD, e.g. Paget disease, osteoporosis, any bone fracture within 6 months before study, multiple myeloma or any neoplastic disease, liver or biliary tract disease, primary hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevelamer HydrochlorideAlso: RenagelSingle 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 | Drug | lanthanum carbonate, sevelamer hydrochloride |
| Lanthanum CarbonateAlso: FosrenolSingle oral doses of lanthanum (1000 mg) | Drug | lanthanum carbonate, sevelamer hydrochloride |
Primary outcome
the change of serum calcium for 24 hours after each drug
Time frame: 3, 6, 12 and 24 hours after administration of each drug
absolute change vs baseline and 24h area under the curve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 34754193Makowka A, Nowicki M. Different Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Calcium Balance in Patients with Moderate to Advanced Chronic Kidney Disease. Ther Clin Risk Manag. 2021 Nov 2;17:1145-1151. doi: 10.2147/TCRM.S330649. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Nowicki, Prof.MD PhD principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevelamer Hydrochloride and Lanthanum Carbonate in people with Chronic Kidney Disease, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of serum calcium for 24 hours after each drug (time frame: 3, 6, 12 and 24 hours after administration of each drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03451019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.