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Double Blind Randomized Placebo Controlled Trial of FOSTRAP Chewing Gum in Patients With CKD and Hyperphosphatemia

Primary Purpose

Hyperphosphatemia, Chronic Kidney Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FOSTRAP Chewing Gum
FOSTRAP Chewing Gum
FOSTRAP Chewing Gum
FOSTRAP Chewing Gum
Placebo chewing gum
Sponsored by
Denver Nephrologists, P.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Hyperphosphatemia, chronic kidney disease, salivary phosphorus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;
  4. Subject must be able to communicate and be able to understand and comply with the requirements of the study;
  5. 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;
  6. For subjects with CKD not on dialysis- a screening serum phosphorus value greater than or equal to 4.5 mg/dL;
  7. 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;
  8. 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;
  9. Subjects with ESRD must have an historical URR ≥ 65% for at least 4 weeks prior to baseline;
  10. All subjects must have NO change in prescribed dose or frequency of any of the following medications ≥ 14 days prior to baseline:

    1. Phosphate binding products including prescribed and over-the counter
    2. Oral or injectable active vitamin D
    3. Oral nutritional vitamin D
    4. Calcimimetics
    5. Calcium supplements
    6. Anti-osteoporotic medication (e.g. bisphosphonates)
  11. 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
  12. Subjects must have a screening salivary flow rate by Saxon test ≥ 1 g/2 min.

Exclusion criteria:

  1. Receiving or has received an investigational product (or is currently using an investigational device) within 28 days prior to baseline;
  2. Known sensitivity to chitin or allergy to shellfish;
  3. Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin;
  4. Clinically significant infection requiring treatment with antibiotics (within 7 days prior to baseline);
  5. Inpatient hospitalization within 14 days prior to baseline with the exception of hospitalizations related to vascular access procedures;
  6. Planned surgical intervention for secondary hyperparathyroidism;
  7. In the opinion of the investigator, inability to chew gum for 60 minutes;
  8. Planned relocation to another area within the next 4 months;
  9. Subject has a known history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result;
  10. Active drug or alcohol dependence or abuse (excluding tobacco use) in the opinion of the principal investigator;
  11. Unstable medical condition which in the opinion of the investigator would compromise successful completion of the study;
  12. Known active liver disease with AST or ALT levels greater than 3X the upper limit of normal; and
  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;

    1. Acute myocardial infarction
    2. Acute cerebral vascular event
    3. Vascular surgical intervention
    4. Coronary Revascularization
    5. Decompensated congestive heart failure

Sites / Locations

  • Denver Nephrologists, PC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

ESRD: FOSTRAP Chewing Gum

CKD: FOSTRAP Chewing Gum

ESRD Matching Placebo

CKD Matching Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in serum phosphorus from baseline to Day 29

Secondary Outcome Measures

Change in salivary phosphorus from baseline to Day 29
Proportion of subjects whose serum phosphorus reduction from baseline to Day 29 is greater than or equal to 0.5 mg/dL
Proportion of subjects whose serum phosphorus reduction from baseline to Day 29 is greater than or equal to 1.5 mg/dL
Change in serum phosphorus from Day 57 to day 71 for subjects with ESRD
For subjects with ESRD absolute and relative difference between serum phosphorus (baseline to Day 29)- (Day 57 to day 71)
Change in salivary phosphorus from Day 57 to Day 71

Full Information

First Posted
January 25, 2010
Last Updated
January 5, 2011
Sponsor
Denver Nephrologists, P.C.
Collaborators
CM&D Pharma Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01057108
Brief Title
Double Blind Randomized Placebo Controlled Trial of FOSTRAP Chewing Gum in Patients With CKD and Hyperphosphatemia
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Denver Nephrologists, P.C.
Collaborators
CM&D Pharma Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The phosphorus content in saliva is increased in chronic kidney disease. We hypothesize that a chewing gum that binds salivary phosphorus would be a novel, effective agent to reduce serum levels of phosphorus in patients with chronic kidney disease. We are testing this hypothesis using a chewing gum called FOSTRAP which has been shown to be effective in a small, non-randomized study in patients with chronic kidney disease on hemodialysis.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, Chronic Kidney Disease
Keywords
Hyperphosphatemia, chronic kidney disease, salivary phosphorus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESRD: FOSTRAP Chewing Gum
Arm Type
Active Comparator
Arm Title
CKD: FOSTRAP Chewing Gum
Arm Type
Active Comparator
Arm Title
ESRD Matching Placebo
Arm Type
Placebo Comparator
Arm Title
CKD Matching Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
FOSTRAP Chewing Gum
Intervention Description
20 mg BID
Intervention Type
Other
Intervention Name(s)
FOSTRAP Chewing Gum
Intervention Description
40 mg BID
Intervention Type
Other
Intervention Name(s)
FOSTRAP Chewing Gum
Intervention Description
20 mg TID
Intervention Type
Other
Intervention Name(s)
FOSTRAP Chewing Gum
Intervention Description
20 mg TID
Intervention Type
Other
Intervention Name(s)
Placebo chewing gum
Primary Outcome Measure Information:
Title
Change in serum phosphorus from baseline to Day 29
Time Frame
Day 1 and Day 29
Secondary Outcome Measure Information:
Title
Change in salivary phosphorus from baseline to Day 29
Time Frame
Day and Day 29
Title
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
Title
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
Title
Change in serum phosphorus from Day 57 to day 71 for subjects with ESRD
Time Frame
Day 57 and Day 71
Title
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
Title
Change in salivary phosphorus from Day 57 to Day 71
Time Frame
Day 57 and Day 71

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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; 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey A Block, MD
Organizational Affiliation
Denver Nephrologists, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Nephrologists, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23797006
Citation
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.
Results Reference
derived

Learn more about this trial

Double Blind Randomized Placebo Controlled Trial of FOSTRAP Chewing Gum in Patients With CKD and Hyperphosphatemia

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