Double Blind Randomized Placebo Controlled Trial of FOSTRAP Chewing Gum in Patients With CKD and Hyperphosphatemia

NCT01057108 | Completed Phase 1

• 1 other identifier: CMD 002
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

The phosphorus content in saliva is increased in chronic kidney disease. We hypothesize that a chewing gum that binds salivary phosphorus would be a novel, effective agent to reduce serum levels of phosphorus in patients with chronic kidney disease. We are testing this hypothesis using a chewing gum called FOSTRAP which has been shown to be effective in a small, non-randomized study in patients with chronic kidney disease on hemodialysis.

Conditions

Hyperphosphatemia; Chronic Kidney Disease

Keywords

Hyperphosphatemia; chronic kidney disease; salivary phosphorus

Outcome Measures

Primary Outcomes (1)

• Change in serum phosphorus from baseline to Day 29

  Day 1 and Day 29

Secondary Outcomes (6)

• Change in salivary phosphorus from baseline to Day 29

  Day and Day 29

• Proportion of subjects whose serum phosphorus reduction from baseline to Day 29 is greater than or equal to 0.5 mg/dL

  Day 1 and Day 29

• Proportion of subjects whose serum phosphorus reduction from baseline to Day 29 is greater than or equal to 1.5 mg/dL

  Day 1 and Day 29

• Change in serum phosphorus from Day 57 to day 71 for subjects with ESRD

  Day 57 and Day 71

• For subjects with ESRD absolute and relative difference between serum phosphorus (baseline to Day 29)- (Day 57 to day 71)

  Day 29, Day 57, Day 71

Study Arms (4)

ESRD: FOSTRAP Chewing Gum

ACTIVE COMPARATOR

Other: FOSTRAP Chewing Gum

CKD: FOSTRAP Chewing Gum

ACTIVE COMPARATOR

Other: FOSTRAP Chewing Gum

ESRD Matching Placebo

PLACEBO COMPARATOR

Other: Placebo chewing gum

CKD Matching Placebo

PLACEBO COMPARATOR

Other: Placebo chewing gum

Interventions

FOSTRAP Chewing Gum OTHER

20 mg BID

ESRD: FOSTRAP Chewing Gum

Placebo chewing gum OTHER

CKD Matching Placebo; ESRD Matching 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;
• The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board (IRB);
• The subject will, in the opinion of the investigator, be compliant with prescribed therapy;
• Subject must be able to communicate and be able to understand and comply with the requirements of the study;
• For subjects with CKD not on dialysis- kidney function at any stage that in the opinion of the investigator is stable and not expected to initiate dialysis within 3 months;
• For subjects with CKD not on dialysis- a screening serum phosphorus value greater than or equal to 4.5 mg/dL;
• For subjects with ESRD - a screening serum phosphorus value greater than or equal to 4.6 mg/dL and less than or equal to 9.0 mg/dL and one of the two conditions: A mean historical value of the most recent 2 phosphorus measurements ≥ 4.6 and less than or equal to 9.0 mg/dL at the time of written informed consent or A second screening serum phosphorus value greater than or equal to 4.6 mg/dL and less than or equal to 9.0 mg/dL performed not less than 7 days from the date of the previous screening;
• In the opinion of the investigator, subjects with ESRD must be prescribed a stable dialysis regimen (3x/week) for ≥ 4 weeks prior to baseline and must have a stable dialysis access;
• Subjects with ESRD must have an historical URR ≥ 65% for at least 4 weeks prior to baseline;
• All subjects must have NO change in prescribed dose or frequency of any of the following medications ≥ 14 days prior to baseline:
• Phosphate binding products including prescribed and over-the counter
• Oral or injectable active vitamin D
• Oral nutritional vitamin D
• Calcimimetics
• Calcium supplements

You may not qualify if:

• Receiving or has received an investigational product (or is currently using an investigational device) within 28 days prior to baseline;
• Known sensitivity to chitin or allergy to shellfish;
• Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin;
• Clinically significant infection requiring treatment with antibiotics (within 7 days prior to baseline);
• Inpatient hospitalization within 14 days prior to baseline with the exception of hospitalizations related to vascular access procedures;
• Planned surgical intervention for secondary hyperparathyroidism;
• In the opinion of the investigator, inability to chew gum for 60 minutes;
• Planned relocation to another area within the next 4 months;
• Subject has a known history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result;
• Active drug or alcohol dependence or abuse (excluding tobacco use) in the opinion of the principal investigator;
• Unstable medical condition which in the opinion of the investigator would compromise successful completion of the study;
• Known active liver disease with AST or ALT levels greater than 3X the upper limit of normal; and
• Subject has had a major cardiovascular event within 90 days of screening. The investigator should be guided by evidence of any of the following;
• Acute myocardial infarction
• Acute cerebral vascular event

Sponsors & Collaborators

• Denver Nephrologists, P.C.: lead
• CM&D Pharma Limited: 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

• Block GA, Persky MS, Shamblin BM, Baltazar MF, Singh B, Sharma A, Pergola P, Smits G, Comelli MC. Effect of salivary phosphate-binding chewing gum on serum phosphate in chronic kidney disease. Nephron Clin Pract. 2013;123(1-2):93-101. doi: 10.1159/000351850. Epub 2013 Jun 22.

  PMID: 23797006 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; 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

Study Officials

• Geoffrey A Block, MD

  Denver Nephrologists, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 27, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 7, 2011

Record last verified: 2011-01

Locations

US (1)