A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD

NCT00785629 | Completed Results DMC

• 1 other identifier: PNT001
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the ability of 3 commercially available phosphorus binders (calcium acetate, sevelamer carbonate, and lanthanum carbonate) to achieve and maintain a phosphorus level in the normal range in patients with chronic kidney disease.

Conditions

Chronic Kidney Disease

Keywords

phosphorus; secondary hyperparathyroidism; vascular calcification

Outcome Measures

Primary Outcomes (1)

• Serum Phosphorus

  mean serum phosphorus from months 3-9

  months 3-9

Study Arms (4)

Calcium Acetate

ACTIVE COMPARATOR

667 mg with meals

Drug: Calcium acetate

Lanthanum Carbonate

ACTIVE COMPARATOR

500 mg with meals

Drug: Lanthanum Carbonate

Sevelamer Carbonate

ACTIVE COMPARATOR

800 mg with meals

Drug: Sevelamer Carbonate

Placebo

PLACEBO COMPARATOR

with meals

Drug: Placebo

Interventions

Calcium acetate DRUG

Calcium Acetate

Lanthanum Carbonate DRUG

Also known as: Fosrenol

Lanthanum Carbonate

Sevelamer Carbonate DRUG

Also known as: Renvela

Sevelamer Carbonate

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Men or women \> 18 years of age;
• Has signed and dated the most recent informed consent form approved by an IRB;
• Will, in the opinion of the PI, be compliant with prescribed phosphate binder therapy;
• Must be able to communicate with the investigator, and be able to understand and comply with the requirements of the study;
• Has a life expectancy \>12 months;
• An eGFR rate (estimated by the MDRD equation) ≥ 20 and ≤ 45 mL/min/1.73m2 obtained by screening laboratory values and in the opinion of the investigator felt to have CKD without evidence of recent acute kidney injury or unexpected decline in renal function;
• A screening serum phosphorus value \> 3.5 mg/dL and ≤ 6.0 mg/dL;
• Must consume a minimum of 2 meals per day and be willing to avoid intentional changes in diet;
• Women of child bearing potential must be practicing an acceptable form of birth control.

You may not qualify if:

• Receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to baseline;
• Subject is pregnant, is breast feeding or is of child bearing potential and not using acceptable birth control measures;
• Has had a previous renal transplant;
• Has a chronic reliance on enemas or laxatives;
• Has a known sensitivity or previous intolerance to any of the products to be administered during the study;
• Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin;
• Currently has an active infection or is being treated with antibiotics (within 14 days prior to baseline);
• Has been hospitalized within 30 days prior to baseline (with the exception of hospitalizations due to vascular access procedures);
• Any surgical or medical condition which might significantly alter the function of phosphorus binders or which may jeopardize the subject in case of participation in the study. The investigator should be guided by evidence of any of the following: Severe gastrointestinal motility disorder,Bowel obstruction,Dysphagia or other disorders of swallowing, Acute peptic ulcer, Ulcerative colitis or Crohn's disease, History of major gastrointestinal tract surgery, Severe malabsorption;
• Currently taking any of the following within 14 days prior to baseline; Calcitriol or its analogs, Cinacalcet hydrochloride, Medications prescribed for the purpose of phosphorus binding;
• Screening serum intact PTH \>500 pg/mL;
• Screening corrected calcium \< 8.0 mg/dL or \> 10.4 mg/dL;
• Uncontrolled hyperlipidemia in the opinion of the PI;
• Initiation of chronic maintenance hemodialysis planned within 12 months;
• Relocation to another area planned within 12 months;

Sponsors & Collaborators

• Denver Nephrologists, P.C.: lead
• Shire: collaborator
• Fresenius Medical Care North America: collaborator
• Genzyme, a Sanofi Company: collaborator
• Novartis Pharmaceuticals: collaborator
• DaVita, Inc.: collaborator

Study Sites (1)

Denver Nephrologists, PC

Denver, Colorado, 80230, United States

Location

Related Publications (2)

• Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

  PMID: 40576086 DERIVED

• Dougher CE, Rifkin DE, Anderson CA, Smits G, Persky MS, Block GA, Ix JH. Spot urine sodium measurements do not accurately estimate dietary sodium intake in chronic kidney disease. Am J Clin Nutr. 2016 Aug;104(2):298-305. doi: 10.3945/ajcn.115.127423. Epub 2016 Jun 29.

  PMID: 27357090 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary; Vascular Calcification

Interventions

calcium acetate; lanthanum carbonate; Sevelamer

Condition Hierarchy (Ancestors)

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; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Limitations and Caveats

Single center study; Modest size of study; pilot study not powered to detect differences among subgroups of actively treated patients

Results Point of Contact

• Title: Geoffrey A. Block, MD
• Organization: Denver Nephrologists, P.C.

gablock@denverneph.net

303-364-4775

Study Officials

• Geoffrey A Block, MD

  Denver Nephrologists, PC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: February 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 30, 2012
• Results First Posted: October 30, 2012

Record last verified: 2012-09

Locations

US (1)