A Study to Evaluate Chitosan Chewing Gum in Patients With Chronic Kidney Disease

NCT01475760 | Completed

• 1 other identifier: CMD007
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine the efficacy of chitosan chewing gum (K2CG) in reducing serum phosphorus in subjects with chronic kidney disease.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease; serum phosphorus; salivary phosphorus; FGF23

Outcome Measures

Primary Outcomes (1)

• serum phosphorus

  Change in serum phosphorus from baseline to mean of values during 2 week active chewing period in patients with CKD not on dialysis

  change from baseline to mean during 2 weeks active therapy

Secondary Outcomes (2)

• serum phosphorus

  change from baseline after 2 weeks active chewing

• salivary phosphorus

  change from baseline to mean during active therapy -2 weeks

Study Arms (3)

K2CG chewing gum (20 mg chitosan)

ACTIVE COMPARATOR

Other: K2CG chewing gum (20mg chitosan)

K2CG chewing gum (60 mg chitosan)

ACTIVE COMPARATOR

Other: K2CG chewing gum (60mg chitosan)

Standard of Care

NO INTERVENTION

Interventions

K2CG chewing gum (20mg chitosan) OTHER

All participating subjects will chew gum TID for 14 days beginning on Day 1 through Day 14

K2CG chewing gum (20 mg chitosan)

K2CG chewing gum (60mg chitosan) OTHER

Subjects will be randomized in a 1:1 fashion to either chew gum or continue with Standard of Care (no intervention)if they have a change in serum phosphorus of greater than or equal to -0.2 mg/dL from: Baseline (defined as the mean of values from Visit 2, 3, and 4) to the end of active treatment (defined as the mean of Visit 6 and 7) AND/OR Baseline (defined as the mean of values from Visit 2, 3, and 4) and end of wash out (defined as Visit 7 (Day 22). If randomized: Chew gum TID for 14 days beginning on Day 29 through Day 42

K2CG chewing gum (60 mg chitosan)

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 and all study visits;
• Subject must be able to communicate and be able to understand and comply with the requirements of the study;
• For subjects not on dialysis estimated GFR at screening \< or equal to 60 ml/min + 10 % that in the opinion of the investigator is stable and not expected to initiate dialysis within 3 months;
• Subject must have serum phosphorus at screening of greater than or equal to 3.5 mg/dL;
• Subjects must have a screening salivary flow rate by Saxon test ≥ 1 g/2 min;
• All subjects must have NO change in prescribed dose or frequency of any of the following medications ≥ 14 days prior to Run-In Visit 2 (Day -15):
• a. Phosphate binding products including prescribed and over-the counter b. Oral or injectable active vitamin D c. Oral nutritional vitamin D d. Calcium supplements e. Anti-osteoporotic medication (e.g. bisphosphonates) f. Cinacalcet i. Subject must be prescribed a diet appropriate for patients with their stage of CKD, must be willing to avoid intentional changes in diet and must have stable nutritional status in the opinion of the investigator.
• j. Subjects on dialysis must, in the opinion of the investigator, have a stable dialysis prescription, stable dialysis access and a URR \>/= 65% for at least 4 weeks prior to Day -15.

You may not qualify if:

• Subject is receiving or has received an investigational product (or is currently using an investigational device) within 14 days prior to Visit 2 (Day -15);
• Subject has a known sensitivity to chitin or allergy to shellfish;
• Subject has had dental work other than cleaning, cavity filling or crown placement within 48 hours prior to Visit 4 (Day 1) or at any time during the course of the trial;
• Subject has a clinically significant infection requiring treatment with antibiotics (within 7 days prior to Visit 2 (Day -15));
• Subject has had an inpatient hospitalization within 14 days prior to Visit 2 (Day -15) with the exception of hospitalizations related to vascular access procedures;
• 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;
• In the opinion of the investigator, subject is unable to chew gum for 30 minutes;
• Subject has an unstable medical condition which in the opinion of the investigator would compromise successful completion of the study;
• Subject is receiving calcimimetic therapy (acceptable if subject is on dialysis);
• Subject has known salivary gland dysfunction or Sjogren's syndrome;
• Subjects is receiving niacin therapy within 7 days prior to Run- In Visit 2(Day -15) (use as part of standard multivitamin is acceptable);
• Subject has had a major cardiovascular event within 90 days of screening. The investigator should be guided by evidence of any of the following;
• a. Acute myocardial infarction b. Acute cerebral vascular event c. Vascular surgical intervention d. Coronary Revascularization e. Decompensated congestive heart failure

Sponsors & Collaborators

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

Study Sites (4)

Southwest Clinical Reserach Institute, LLC

Tempe, Arizona, 85284, United States

Location

Denver Nephrologists, PC

Denver, Colorado, 80230, United States

Location

Pacific Renal Research Institute

Meridian, Idaho, 83642, United States

Location

Renal Associates, PA

San Antonio, Texas, 78215, 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

Renal Insufficiency, Chronic

Interventions

Chitosan

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

Intervention Hierarchy (Ancestors)

Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Officials

• Geoffrey Block, MD

  DenverNephrologists, P.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 21, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

US (4)