Phosphate Binding of Chitosan Chewing Gum in Patients With Chronic Kidney Disease (CKD)

Launched by DENVER NEPHROLOGISTS, P.C. · Apr 25, 2011

Keywords

ClinConnect Summary

The current treatment for elevated serum phosphorus levels in chronic kidney disease (CKD) consists of dietary restriction of P and the provision of phosphate binders that act at the level of the intestinal absorption of phosphorus (P) when ingested with meals. This paradigm has proven to be inadequate to achieve normo-phosphatemia as indicated by elevated serum P levels in patients receiving renal replacement therapy.

Salivary phosphate levels are elevated in patients with CKD and salivary P represents a large source of otherwise hidden non-dietary phosphate that is easily absorbed and ma...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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;
• • Subject must be prescribed a diet appropriate for patients with their stage of CKD and must be willing to avoid intentional changes in diet; and
• • Subject must have completed the CMD002 clinical trial and is currently receiving hemodialysis.
• Exclusion Criteria:
• • Subject is receiving or has received an investigational product (or is currently using an investigational device) within 7 days prior to baseline;
• • Subject has a known sensitivity to chitin or allergy to shellfish;
• • Subject has a clinically significant infection requiring treatment with antibiotics (within 7 days prior to baseline);
• • Subject has had an inpatient hospitalization within 7 days prior to baseline with the exception of hospitalizations related to vascular access procedures; In the opinion of the investigator, subject is unable to chew gum for 60 minutes; and
• • Subject has an unstable medical condition which in the opinion of the investigator would compromise successful completion of the study;