Dose Finding Study to Treat High Phosphate Levels in the Blood.
NCT ID: NCT02081534
Last Updated: 2020-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
162 participants
INTERVENTIONAL
2014-03-31
2014-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1 mg bid
1 mg AZD1722 bid
AZD1722
AZD1722, oral tablet
3 mg bid
3 mg AZD1722 bid
AZD1722
AZD1722, oral tablet
10 mg bid
10 mg AZD1722 bid
AZD1722
AZD1722, oral tablet
30 mg bid
30 mg AZD1722 bid
AZD1722
AZD1722, oral tablet
3 mg od
3 mg AZD1722 od
AZD1722
AZD1722, oral tablet
30 mg od
30 mg AZD1722 od
AZD1722
AZD1722, oral tablet
Placebo
Placebo (double dummy technique)
Placebo
Placebo bid, double dummy technique
Interventions
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AZD1722
AZD1722, oral tablet
Placebo
Placebo bid, double dummy technique
Eligibility Criteria
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Inclusion Criteria
2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months
3. Prescribed and taking at least 3 doses of phosphate binder per day
4. 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
5. Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
6. 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
2. Serum parathyroid hormone \>1200 pg/mL
3. Significant metabolic acidosis
4. Clinical signs of hypovolemia at randomization
\-
18 Years
85 Years
ALL
No
Sponsors
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Ardelyx
INDUSTRY
Responsible Party
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Principal Investigators
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Geoffrey A Block, MD
Role: PRINCIPAL_INVESTIGATOR
Denver Nephrology PC, Denver, CO 80230
Locations
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Research Site
Downey, California, United States
Research Site
Los Angeles, California, United States
Research Site
Sacramento, California, United States
Research Site
Whittier, California, United States
Research Site
Denver, Colorado, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Springfield, Massachusetts, United States
Research Site
Detroit, Michigan, United States
Research Site
Voorhees Township, New Jersey, United States
Research Site
Flushing, New York, United States
Research Site
Maspeth, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
San Antonio, Texas, United States
Research Site
Bialystok, , Poland
Research Site
Częstochowa, , Poland
Research Site
Działdowo, , Poland
Research Site
Legnica, , Poland
Research Site
Lublin, , Poland
Research Site
Radom, , Poland
Research Site
Szczecin, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Zamość, , Poland
Research Site
Zgierz, , Poland
Research Site
Żary, , Poland
Research Site
Banská Bystrica, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Hlohovec, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Piešťany, , Slovakia
Research Site
Púchov, , Slovakia
Research Site
Senica, , Slovakia
Research Site
Birmingham, , United Kingdom
Research Site
Doncaster, , United Kingdom
Research Site
Exeter, , United Kingdom
Research Site
Hull, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
London, , United Kingdom
Countries
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References
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Sprague SM, Weiner DE, Tietjen DP, Pergola PE, Fishbane S, Block GA, Silva AL, Fadem SZ, Lynn RI, Fadda G, Pagliaro L, Zhao S, Edelstein S, Spiegel DM, Rosenbaum DP. Tenapanor as Therapy for Hyperphosphatemia in Maintenance Dialysis Patients: Results from the OPTIMIZE Study. Kidney360. 2024 May 1;5(5):732-742. doi: 10.34067/KID.0000000000000387. Epub 2024 Feb 7.
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.
Other Identifiers
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D5613C00001
Identifier Type: -
Identifier Source: org_study_id
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