Chronic Kidney FailureNCT01581996
Fosrenol and Phosphorus Balance - Lanthanum Carbonate
A study testing lanthanum carbonate in people with Chronic Kidney Failure and End-stage Renal Disease, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
Positive phosphorus balance and hyperphosphatemia (increased serum phosphorus levels) are very common complications of people with advanced chronic kidney disease (i.e., stage 5 CKD), including chronic dialysis patients, and are associated with severe morbidity and increased mortality. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Chronic Kidney Failure, End-stage Renal Disease, Disorders Associated With Peritoneal Dialysis
- What is being tested?
- lanthanum carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 2017
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic peritoneal dialysis treatment(CPD) for at least the previous six months, Clinically stable,
- Ages 30 to 65 years old,
- Both genders,
- Any racial or ethnic background,
- Evidence that the subject is capable of giving informed consent and of adhering to the study protocol.
Who cannot join
- No inflammatory or catabolic illnesses.
- No hospitalizations within the previous three months except for vascular access revision,
- No severe heart, liver or lung failure,
- No cancer, other than basal cell carcinoma, systemic infections, vasculitis or other rheumatological diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Official title: Effect of Lanthanum Carbonate (Fosrenol) on Fecal Phosphorus Excretion and Phosphorus Balance
Positive phosphorus balance and hyperphosphatemia (increased serum phosphorus levels) are very common complications of people with advanced chronic kidney disease (i.e., stage 5 CKD), including chronic dialysis patients, and are associated with severe morbidity and increased mortality. Despite attempts to control serum phosphorus with dietary phosphorus restriction and the use of medicines that bind phosphorus in the gastrointestinal tract so that the phosphorus cannot be absorbed into the body( also called phosphate binders), chronic dialysis patients frequently remain hyperphosphatemic, particularly at the time when they commence each of their regular dialysis treatments.
Fosrenol (lanthanum carbonate, manufactured by Shire Pharmaceuticals) is a gastrointestinal phosphate binder that appears to have the advantages of being safe, well tolerated and effective at binding phosphate. There are limited data on the magnitude of binding of phosphorus by Fosrenol in the human gastrointestinal tract of patients with chronic kidney disease.
Read more
The specific aims for this proposal are as follows:
- To quantify, under precisely controlled metabolic balance conditions, the increase in fecal excretion of dietary phosphorus that occurs when patients undergoing chronic peritoneal dialysis (CPD) ingest Fosrenol (lanthanum carbonate).
- To examine a dose response relationship between Fosrenol treatment and fecal phosphorus excretion. The investigators will examine in CPD patients ingesting a constant phosphorus intake, how much additional phosphorus is excreted in the feces at three different dose levels of Fosrenol, 1.5, 3.0, and 4.5 g/day.
- To examine how increased fecal phosphorus losses and more negative phosphorus balance caused by Fosrenol intake affects serum phosphorus and such hormonal regulators of phosphorus metabolism as serum parathyroid hormone (PTH), fibroblast growth factor-23, 25-hydroxycholecalciferol (25(OH)D3), 1,25-dihydroxycholecalciferol (1,25(OH)2D3) and fetuin-A.
- To assess whether there is any effect of Fosrenol and increased intestinal phosphate binding on protein-nitrogen balance.
Read the detailed description
Seven clinically stable patients who have been undergoing CPD for at least six months will be admitted to the General Clinical and Research Center (GCRC) at Harbor-UCLA Medical Center for 46 days. During this time they will be fed, under strict metabolic balance study conditions, a constant energy and protein intake designed to meet their previously ascertained nutritional needs. Their dietary intakes of phosphorus, calcium and magnesium will be maintained constant throughout the 46 days of study at 1100 mg/day, 1000 mg/day and 200 mg/day, respectively. Patients will be treated throughout the study with a constant peritoneal dialysis regimen that consists of either continuous ambulatory peritoneal dialysis with four dialysate exchanges daily or automated peritoneal dialysis in which they will each receive about four dialysate exchanges per night; and possibly day-time dialysate exchanges. The number and volume of dialysate exchanges and the dialysate glucose concentration may vary among patients according to their metabolic and clinical needs, but will be constant for each patient. Patients will adhere to standard metabolic balance protocols as the investigators have conducted during our many previous metabolic balance studies. These protocols will include participating in prescribed daily exercise regimens that are designed to maintain the patients' physical activity at their prestudy, outpatient levels.
All patients will first undergo a 10 day Baseline period for metabolic equilibration during which time they will not receive any phosphate binder. They will then receive three periods of Fosrenol treatment with three different dose levels for 12 days each. During each of three periods, the patients will receive, in random order, one or two Fosrenol tablets that will provide 500, 1000, or 1500 mg with each of the three meals that they will be fed each day. Thus these CPD patients will receive in random order 1500, 3000 and 4500 mg/day of Fosrenol each prescribed for one 12 day period.
Outcome Measurements. All urine, collected in 24 hour urine specimens, and all feces excreted, collected over four day periods, will be obtained continuously. Every 4 days a duplicate 24 hour diet will be prepared for chemical analyses. The above specimens will be analyzed for phosphorus, calcium and nitrogen by spectrographic, atomic absorption spectroscopic and Kjeldahl analyses, respectively. Serum phosphorus, calcium, parathyroid hormone (PTH), fibroblast growth factor-23, 25-hydroxycholecalciferol (25(OH)D3), 1,25-dihydroxycholecalciferol (1,25(OH)2D3), fetuin-A, urea and creatinine will be measured in the fasting state at the beginning of the 40 day balance period and every 5 days. Anthropometry and other standard measurements that are routinely conducted during metabolic balance procedures will also be performed.
- Conditions
- Chronic Kidney Failure, End-stage Renal Disease, Disorders Associated With Peritoneal Dialysis
- Being tested
- lanthanum carbonate
- Keywords
- Chronic renal failure, End-stage renal disease, Chronic peritoneal dialysis, Serum phosphorus, Hyperphosphatemia, Phosphate binders, Phosphate
- Medical subject headings
- Kidney Failure, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lanthanum carbonateDrug
Also called Fosrenol
All patients will receive the following doses of lanthanum carbonate in random order for 10 -12 days each. O mg, 500 mg tid, 1000 mg tid, 1500 mg tid.
| Study group | Role | What they receive |
|---|---|---|
| Lanthanum carbonate treatment | Experimental | One Treatment arm. All patients will receive the following doses of lanthanum carbonate(Fosrenol)for 10-12 days each: 0 mg, 500 mg tid, 1000 mg tid and 1500 mg tid. Receives: Drug: lanthanum carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Phosphorus and Body Phosphorus Balance
Dose response relationship between lanthanum carbonate(Fosrenol) intake and fecal phosphorus excretion and body phosphorus balance. Specifically, the phosphorus content of feces, urine, expended dialysate, diet and any vomitus or rejected food will be measured.
Measured: Two years
Secondary outcomes (3)
Fecal Calcium and Nitrogen and Body Calcium and Nitrogen Balance
Fecal calcium and nitrogen and calcium and nitrogen balance in chronic peritoneal dialysis patients eating lanthanum carbonate (Fosrenol) intake. Effect of ingestion of Fosrenol on serum phosphorus and hormonal regulators of phosphorus metabolism as serum, parathyroid hormone (PTH), fibroblast growth factor-23, 25-hydroxycholecalciferol (25(OH)D3), 1,25-dihydroxycholecalciferol (1,25(OH)2D3) and fetuin-A.
Measured: Two years
Protein-nitrogen balance
Lanthanum carbonate (Fosrenol) and increased intestinal phosphate binding on protein-nitrogen balance.
Measured: Two years
Gastrointestinal symptoms
Gastrointestinal symptoms, particularly for anorexia, nausea vomiting, abdominal pain, distention, flatulence, constipation, diarrhea.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2017
- Study completionMay 2017
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 FailureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel D. Kopple, M.D., Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581996
- Sponsor's protocol ID
- 20266-01
- Status last verified
- May 2017
- First submitted
- 9 Apr 2012
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kopple JD, Bross R, Ekramzadeh M, Markovic D, Lyzlov A, Lodebo BT, Mehrotra R, Shah AP. Lanthanum carbonate lowers serum phosphorus without altering body phosphorus burden in maintenance peritoneal dialysis patients: a randomized crossover trial. Am J Clin Nutr. 2025 Dec;122(6):1858-1868. doi: 10.1016/j.ajcnut.2025.08.015. Epub 2025 Oct 1.
PubMed 41033875
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lanthanum Carbonate (Fosrenol) on Fecal Phosphorus Excretion and Phosphorus Balance
- ClinicalTrials.gov ID
- NCT01581996
- Acronym / sponsor ID
- 20266-01
- Conditions
- Chronic Kidney Failure, End-stage Renal Disease, Disorders Associated With Peritoneal Dialysis
- Keywords
- Chronic renal failure, End-stage renal disease, Chronic peritoneal dialysis, Serum phosphorus, Hyperphosphatemia, Phosphate binders, Phosphate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 20 Apr 2012 (estimated)
- 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.
Positive phosphorus balance and hyperphosphatemia (increased serum phosphorus levels) are very common complications of people with advanced chronic kidney disease (i.e., stage 5 CKD), including chronic dialysis patients, and are associated with severe morbidity and increased mortality. Despite attempts to control serum phosphorus with dietary phosphorus restriction and the use of medicines that bind phosphorus in the gastrointestinal tract so that the phosphorus cannot be absorbed into the body( also called phosphate binders), chronic dialysis patients frequently remain hyperphosphatemic, particularly at the time when they commence each of their regular dialysis treatments.
Fosrenol (lanthanum carbonate, manufactured by Shire Pharmaceuticals) is a gastrointestinal phosphate binder that appears to have the advantages of being safe, well tolerated and effective at binding phosphate. There are limited data on the magnitude of binding of phosphorus by Fosrenol in the human gastrointestinal tract of patients with chronic kidney disease.
The specific aims for this proposal are as follows:
- To quantify, under precisely controlled metabolic balance conditions, the increase in fecal excretion of dietary phosphorus that occurs when patients undergoing chronic peritoneal dialysis (CPD) ingest Fosrenol (lanthanum carbonate).
- To examine a dose response relationship between Fosrenol treatment and fecal phosphorus excretion. The investigators will examine in CPD patients ingesting a constant phosphorus intake, how much additional phosphorus is excreted in the feces at three different dose levels of Fosrenol, 1.5, 3.0, and 4.5 g/day.
- To examine how increased fecal phosphorus losses and more negative phosphorus balance caused by Fosrenol intake affects serum phosphorus and such hormonal regulators of phosphorus metabolism as serum parathyroid hormone (PTH), fibroblast growth factor-23, 25-hydroxycholecalciferol (25(OH)D3), 1,25-dihydroxycholecalciferol (1,25(OH)2D3) and fetuin-A.
- To assess whether there is any effect of Fosrenol and increased intestinal phosphate binding on protein-nitrogen balance.
Detailed description
Seven clinically stable patients who have been undergoing CPD for at least six months will be admitted to the General Clinical and Research Center (GCRC) at Harbor-UCLA Medical Center for 46 days. During this time they will be fed, under strict metabolic balance study conditions, a constant energy and protein intake designed to meet their previously ascertained nutritional needs. Their dietary intakes of phosphorus, calcium and magnesium will be maintained constant throughout the 46 days of study at 1100 mg/day, 1000 mg/day and 200 mg/day, respectively. Patients will be treated throughout the study with a constant peritoneal dialysis regimen that consists of either continuous ambulatory peritoneal dialysis with four dialysate exchanges daily or automated peritoneal dialysis in which they will each receive about four dialysate exchanges per night; and possibly day-time dialysate exchanges. The number and volume of dialysate exchanges and the dialysate glucose concentration may vary among patients according to their metabolic and clinical needs, but will be constant for each patient. Patients will adhere to standard metabolic balance protocols as the investigators have conducted during our many previous metabolic balance studies. These protocols will include participating in prescribed daily exercise regimens that are designed to maintain the patients' physical activity at their prestudy, outpatient levels.
All patients will first undergo a 10 day Baseline period for metabolic equilibration during which time they will not receive any phosphate binder. They will then receive three periods of Fosrenol treatment with three different dose levels for 12 days each. During each of three periods, the patients will receive, in random order, one or two Fosrenol tablets that will provide 500, 1000, or 1500 mg with each of the three meals that they will be fed each day. Thus these CPD patients will receive in random order 1500, 3000 and 4500 mg/day of Fosrenol each prescribed for one 12 day period.
Outcome Measurements. All urine, collected in 24 hour urine specimens, and all feces excreted, collected over four day periods, will be obtained continuously. Every 4 days a duplicate 24 hour diet will be prepared for chemical analyses. The above specimens will be analyzed for phosphorus, calcium and nitrogen by spectrographic, atomic absorption spectroscopic and Kjeldahl analyses, respectively. Serum phosphorus, calcium, parathyroid hormone (PTH), fibroblast growth factor-23, 25-hydroxycholecalciferol (25(OH)D3), 1,25-dihydroxycholecalciferol (1,25(OH)2D3), fetuin-A, urea and creatinine will be measured in the fasting state at the beginning of the 40 day balance period and every 5 days. Anthropometry and other standard measurements that are routinely conducted during metabolic balance procedures will also be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lanthanum carbonate treatment | Experimental | Drug: lanthanum carbonateOne Treatment arm. All patients will receive the following doses of lanthanum carbonate(Fosrenol)for 10-12 days each: 0 mg, 500 mg tid, 1000 mg tid and 1500 mg tid. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic peritoneal dialysis treatment(CPD) for at least the previous six months, Clinically stable,
- Ages 30 to 65 years old,
- Both genders,
- Any racial or ethnic background,
- Evidence that the subject is capable of giving informed consent and of adhering to the study protocol.
Key exclusion criteria (4 listed)
- No inflammatory or catabolic illnesses.
- No hospitalizations within the previous three months except for vascular access revision,
- No severe heart, liver or lung failure,
- No cancer, other than basal cell carcinoma, systemic infections, vasculitis or other rheumatological diseases.
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 |
|---|---|---|
| lanthanum carbonateAlso: FosrenolAll patients will receive the following doses of lanthanum carbonate in random order for 10 -12 days each. O mg, 500 mg tid, 1000 mg tid, 1500 mg tid. | Drug | Lanthanum carbonate treatment |
Primary outcome
Fecal Phosphorus and Body Phosphorus Balance
Time frame: Two years
Dose response relationship between lanthanum carbonate(Fosrenol) intake and fecal phosphorus excretion and body phosphorus balance. Specifically, the phosphorus content of feces, urine, expended dialysate, diet and any vomitus or rejected food will be measured.
3 secondary outcomes
Fecal Calcium and Nitrogen and Body Calcium and Nitrogen Balance
Time frame: Two years
Protein-nitrogen balance
Time frame: Two years
Gastrointestinal symptoms
Time frame: Two years
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 9 May 2017.
- Derived from this study: PubMed 41033875Kopple JD, Bross R, Ekramzadeh M, Markovic D, Lyzlov A, Lodebo BT, Mehrotra R, Shah AP. Lanthanum carbonate lowers serum phosphorus without altering body phosphorus burden in maintenance peritoneal dialysis patients: a randomized crossover trial. Am J Clin Nutr. 2025 Dec;122(6):1858-1868. doi: 10.1016/j.ajcnut.2025.08.015. Epub 2025 Oct 1.
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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.
Joel D. Kopple, M.D. principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lanthanum carbonate in people with Chronic Kidney Failure and End-stage Renal Disease, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
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 5 inclusion and 4 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 9 May 2017. 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 United States. 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.
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?
Fecal Phosphorus and Body Phosphorus Balance (time frame: Two years). 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 NCT01581996, 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 9 May 2017.