- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01057108
Double Blind Randomized Placebo Controlled Trial of FOSTRAP Chewing Gum in Patients With CKD and Hyperphosphatemia
A Double Blind, Randomized, Placebo Controlled Trial to Evaluate the Efficacy and Safety of FOSTRAP Chewing Gum in Patients With Chronic Kidney Disease and Hyperphosphatemia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A double-blind, randomized, placebo, controlled trial with an open label extension for those subjects with end stage renal disease (ESRD).
Patients with ESRD will be randomized to receive either FOSTRAP™ 20 mg BID, FOSTRAP™ 40 mg BID or matching placebo 2x/day. All subjects will participate in a 4 week chewing period followed by a 4 week follow up period. All subjects will then enter an open label 2 week extension phase in which they will receive FOSTRAP™ 20 mg TID.
Patients with chronic kidney disease (CKD) not on dialysis will receive either FOSTRAP™ 20 mg 3x/day or placebo TID for 4 weeks followed by a 4 week follow up period.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80230
- Denver Nephrologists, PC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
- 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
- Anti-osteoporotic medication (e.g. bisphosphonates)
- Subject must be prescribed a diet appropriate for patients with their stage of kidney disease, and must be willing to avoid intentional changes in diet; and
- Subjects must have a screening salivary flow rate by Saxon test ≥ 1 g/2 min.
Exclusion criteria:
- 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
- Vascular surgical intervention
- Coronary Revascularization
- Decompensated congestive heart failure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ESRD: FOSTRAP Chewing Gum
|
20 mg BID
40 mg BID
20 mg TID
|
Active Comparator: CKD: FOSTRAP Chewing Gum
|
20 mg BID
40 mg BID
20 mg TID
|
Placebo Comparator: ESRD Matching Placebo
|
|
Placebo Comparator: CKD Matching Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in serum phosphorus from baseline to Day 29
Time Frame: Day 1 and Day 29
|
Day 1 and Day 29
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in salivary phosphorus from baseline to Day 29
Time Frame: Day and 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
Time Frame: Day 1 and Day 29
|
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
Time Frame: Day 1 and Day 29
|
Day 1 and Day 29
|
Change in serum phosphorus from Day 57 to day 71 for subjects with ESRD
Time Frame: Day 57 and Day 71
|
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)
Time Frame: Day 29, Day 57, Day 71
|
Day 29, Day 57, Day 71
|
Change in salivary phosphorus from Day 57 to Day 71
Time Frame: Day 57 and Day 71
|
Day 57 and Day 71
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Geoffrey A Block, MD, Denver Nephrologists, PC
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMD 002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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