Phosphate Binding of Chitosan Chewing Gum in Patients With Chronic Kidney Disease (CKD)
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Chronic Kidney Disease
In brief
To determine the amount of phosphate recovered into 2 strengths of K2CG chewing gum in a modified formulation (with or without an extender) added to the gum core, in comparison to matching placebo gums.
Key facts
- Study ID
- NCT01341691
- Run by
- Denver Nephrologists, P.C.
- People needed
- 12
- Starts
- 2011-03-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2011-04-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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;
- 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.
You may not qualify if…
- 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;
Where it is running
- Denver Nephrologists, PC — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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