Dose Finding Study to Treat High Phosphate Levels in the Blood.
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)
1 other identifier
interventional
162
4 countries
41
Brief Summary
Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2014
Shorter than P25 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 6, 2014
CompletedFirst Posted
Study publicly available on registry
March 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
September 14, 2020
CompletedSeptember 14, 2020
August 1, 2020
8 months
March 6, 2014
August 6, 2020
August 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Serum Phosphate Levels
Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment
End of wash out (pre randomization value) to end of treatment (Day 29)
Secondary Outcomes (1)
Change From Baseline in Calcium x Phosphorus Product
End of wash out (pre randomization value) to end of treatment (Day 29)
Study Arms (7)
1 mg bid
EXPERIMENTAL1 mg AZD1722 bid
3 mg bid
EXPERIMENTAL3 mg AZD1722 bid
10 mg bid
EXPERIMENTAL10 mg AZD1722 bid
30 mg bid
EXPERIMENTAL30 mg AZD1722 bid
3 mg od
EXPERIMENTAL3 mg AZD1722 od
30 mg od
EXPERIMENTAL30 mg AZD1722 od
Placebo
PLACEBO COMPARATORPlacebo (double dummy technique)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ardelyxlead
Study Sites (41)
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
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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
Related Publications (2)
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.
PMID: 38323855DERIVEDBlock 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.
PMID: 29617976DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Development Officer
- Organization
- Ardelyx
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey A Block, MD
Denver Nephrology PC, Denver, CO 80230
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2014
First Posted
March 7, 2014
Study Start
March 1, 2014
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
September 14, 2020
Results First Posted
September 14, 2020
Record last verified: 2020-08