Fosrenol and Phosphorus Balance - Lanthanum Carbonate

NCT01581996 | Completed DMC

• 1 other identifier: 20266-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.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).
2. 2.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.
3. 3.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.
4. 4.To assess whether there is any effect of Fosrenol and increased intestinal phosphate binding on protein-nitrogen balance.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Two years

Secondary Outcomes (3)

• Fecal Calcium and Nitrogen and Body Calcium and Nitrogen Balance

  Two years

• Protein-nitrogen balance

  Two years

• Gastrointestinal symptoms

  Two years

Study Arms (1)

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.

Drug: lanthanum carbonate

Interventions

lanthanum carbonate DRUG

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.

Also known as: Fosrenol

Lanthanum carbonate treatment

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead

Study Sites (1)

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Related Publications (1)

• 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.

  PMID: 41033875 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Hyperphosphatemia

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Joel D. Kopple, M.D.

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2012
• First Posted: April 20, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

US (1)