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

Launched by DENVER NEPHROLOGISTS, P.C. · Nov 18, 2011

Keywords

ClinConnect Summary

Given the public health importance of increased P levels in the general population and specifically in patients with chronic kidney disease, it is of great importance to evaluate the ability of a medical food such as K2CG to reduce elevated serum P levels. In patients with CKD receiving dialysis it has been estimated that sustained control of serum P may result in an approximate 17% reduction in mortality.

The investigators have conducted a previous pilot double blind randomized controlled study of K2CG 20 mg and 40 mg BID for 4 weeks in 90 patients with ESRD. In this initial study the inv...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Men or women \> 18 years of age;
• • 2. The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board (IRB);
• • 3. The subject will, in the opinion of the investigator, be compliant with prescribed therapy and all study visits;
• • 4. Subject must be able to communicate and be able to understand and comply with the requirements of the study;
• • 5. 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;
• • 6. Subject must have serum phosphorus at screening of greater than or equal to 3.5 mg/dL;
• • 7. Subjects must have a screening salivary flow rate by Saxon test ≥ 1 g/2 min;
• 8. 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.
• Exclusion Criteria:
• • 1. 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);
• • 2. Subject has a known sensitivity to chitin or allergy to shellfish;
• • 3. 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;
• • 4. Subject has a clinically significant infection requiring treatment with antibiotics (within 7 days prior to Visit 2 (Day -15));
• • 5. 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;
• • 6. Subject has a known history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result;
• • 7. Active drug or alcohol dependence or abuse (excluding tobacco use) in the opinion of the principal investigator;
• • 8. In the opinion of the investigator, subject is unable to chew gum for 30 minutes;
• • 9. Subject has an unstable medical condition which in the opinion of the investigator would compromise successful completion of the study;
• • 10. Subject is receiving calcimimetic therapy (acceptable if subject is on dialysis);
• • 11. Subject has known salivary gland dysfunction or Sjogren's syndrome;
• • 12. Subjects is receiving niacin therapy within 7 days prior to Run- In Visit 2(Day -15) (use as part of standard multivitamin is acceptable);
• • 13. 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
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