Back to resultsDose Finding Study to Treat High Phosphate Levels in the Blood.
Primary Purpose
Hyperphosphatemia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD1722
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia focused on measuring S-phosphate, hyperphosphatemia, hemodialysis, ESRD
Eligibility Criteria
Inclusion Criteria:
- Females and males aged ≥18 years
- Chronic maintenance hemodialysis 3 x/week for a at least 3 months
- Prescribed and taking at least 3 doses of phosphate binder per day
- Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
- Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
- For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out
Exclusion Criteria:
- Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
- Serum parathyroid hormone >1200 pg/mL
- Significant metabolic acidosis
Clinical signs of hypovolemia at randomization
-
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1 mg bid
3 mg bid
10 mg bid
30 mg bid
3 mg od
30 mg od
Placebo
Arm Description
1 mg AZD1722 bid
3 mg AZD1722 bid
10 mg AZD1722 bid
30 mg AZD1722 bid
3 mg AZD1722 od
30 mg AZD1722 od
Placebo (double dummy technique)
Outcomes
Primary Outcome Measures
Change in Serum Phosphate Levels
Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment
Secondary Outcome Measures
Change From Baseline in Calcium x Phosphorus Product
Change from baseline (end of wash out) in calcium x phosphorus product
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02081534
Brief Title
Dose Finding Study to Treat High Phosphate Levels in the Blood.
Official Title
A Phase 2b, Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of AZD1722 to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardelyx
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period
Detailed Description
The study consists of a screening period of approximately 1 week, a wash out period of up to 3 weeks, where existing phosphate lowering medication is withheld, a 4-week treatment period and a follow-up period of up to 2 weeks, during which patients are put back on their pre washout phosphate lowering medication.
The wash out period will be either 1 week, 2 weeks or 3 weeks depending on the increase in s-phosphate levels.
There are 7 parallel treatment arms in the study with bid and od treatment regimens.
Laboratory efficacy endpoints and safety assessments will be evaluated at various times throughout the study.
The target population of the study is: male or female patients, above18 years of age with End Stage Renal Disease (ESRD) on chronic maintenance hemodialysis (HD) 3 times a week for a minimum of 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia
Keywords
S-phosphate, hyperphosphatemia, hemodialysis, ESRD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 mg bid
Arm Type
Experimental
Arm Description
1 mg AZD1722 bid
Arm Title
3 mg bid
Arm Type
Experimental
Arm Description
3 mg AZD1722 bid
Arm Title
10 mg bid
Arm Type
Experimental
Arm Description
10 mg AZD1722 bid
Arm Title
30 mg bid
Arm Type
Experimental
Arm Description
30 mg AZD1722 bid
Arm Title
3 mg od
Arm Type
Experimental
Arm Description
3 mg AZD1722 od
Arm Title
30 mg od
Arm Type
Experimental
Arm Description
30 mg AZD1722 od
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (double dummy technique)
Intervention Type
Drug
Intervention Name(s)
AZD1722
Intervention Description
AZD1722, oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo bid, double dummy technique
Primary Outcome Measure Information:
Title
Change in Serum Phosphate Levels
Description
Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment
Time Frame
End of wash out (pre randomization value) to end of treatment (Day 29)
Secondary Outcome Measure Information:
Title
Change From Baseline in Calcium x Phosphorus Product
Description
Change from baseline (end of wash out) in calcium x phosphorus product
Time Frame
End of wash out (pre randomization value) to end of treatment (Day 29)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Females and males aged ≥18 years
Chronic maintenance hemodialysis 3 x/week for a at least 3 months
Prescribed and taking at least 3 doses of phosphate binder per day
Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out
Exclusion Criteria:
Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
Serum parathyroid hormone >1200 pg/mL
Significant metabolic acidosis
Clinical signs of hypovolemia at randomization
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey A Block, MD
Organizational Affiliation
Denver Nephrology PC, Denver, CO 80230
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Downey
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
Research Site
City
Whittier
State/Province
California
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Flushing
State/Province
New York
Country
United States
Facility Name
Research Site
City
Maspeth
State/Province
New York
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Czestochowa
Country
Poland
Facility Name
Research Site
City
Dzialdowo
Country
Poland
Facility Name
Research Site
City
Legnica
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Radom
Country
Poland
Facility Name
Research Site
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Zamosc
Country
Poland
Facility Name
Research Site
City
Zary
Country
Poland
Facility Name
Research Site
City
Zgierz
Country
Poland
Facility Name
Research Site
City
Banska Bystrica
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Hlohovec
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Piestany
Country
Slovakia
Facility Name
Research Site
City
Puchov
Country
Slovakia
Facility Name
Research Site
City
Senica
Country
Slovakia
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Doncaster
Country
United Kingdom
Facility Name
Research Site
City
Exeter
Country
United Kingdom
Facility Name
Research Site
City
Hull
Country
United Kingdom
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29617976
Citation
Block GA, Rosenbaum DP, Yan A, Greasley PJ, Chertow GM, Wolf M. The effects of tenapanor on serum fibroblast growth factor 23 in patients receiving hemodialysis with hyperphosphatemia. Nephrol Dial Transplant. 2019 Feb 1;34(2):339-346. doi: 10.1093/ndt/gfy061.
Results Reference
derived
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Dose Finding Study to Treat High Phosphate Levels in the Blood.
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