HyperphosphatemiaPhase 2NCT02081534
Dose Finding Study to Treat High Phosphate Levels in the Blood.
A Phase 2 study testing AZD1722 in people with Hyperphosphatemia, run by Ardelyx at 41 sites in 4 countries.
Trial summary
Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- AZD1722
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 41 sitesin 4 countries
- Study dates
- Mar 2014to Nov 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
41 sites in 4 countries.
41 sites in 4 countries
United States16 sites
Research Site
Charlotte, North Carolina
Research Site
Cincinnati, Ohio
Research Site
Denver, Colorado
Research Site
Detroit, Michigan
Research Site
Downey, California
Research Site
Flushing, New York
Research Site
Los Angeles, California
Research Site
Maspeth, New York
Research Site
Pembroke Pines, Florida
Research Site
Sacramento, California
Research Site
San Antonio, Texas
Research Site
Springfield, Massachusetts
Research Site
Tampa, Florida
Research Site
Voorhees Township, New Jersey
Research Site
Whittier, California
Research Site
Winter Park, Florida
Poland12 sites
Research Site
Bialystok
Research Site
Częstochowa
Research Site
Działdowo
Research Site
Legnica
Research Site
Lublin
Research Site
Radom
Research Site
Szczecin
Research Site
Warsaw
Research Site
Wroclaw
Research Site
Zamość
Research Site
Żary
Research Site
Zgierz
Slovakia7 sites
Research Site
Banská Bystrica
Research Site
Bratislava
Research Site
Hlohovec
Research Site
Košice
Research Site
Piešťany
Research Site
Púchov
Research Site
Senica
United Kingdom6 sites
Research Site
Birmingham
Research Site
Doncaster
Research Site
Exeter
Research Site
Hull
Research Site
Leicester
Research Site
London
About this study
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)
Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period
Read the 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.
- Conditions
- Hyperphosphatemia
- Being tested
- AZD1722, Placebo
- Keywords
- S-phosphate, hyperphosphatemia, hemodialysis, ESRD
- Medical subject headings
- Hyperphosphatemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1722Drug
AZD1722, oral tablet
PlaceboDrug
Placebo bid, double dummy technique
| Study group | Role | What they receive |
|---|---|---|
| 1 mg bid | Experimental | 1 mg AZD1722 bid Receives: Drug: AZD1722 |
| 3 mg bid | Experimental | 3 mg AZD1722 bid Receives: Drug: AZD1722 |
| 10 mg bid | Experimental | 10 mg AZD1722 bid Receives: Drug: AZD1722 |
| 30 mg bid | Experimental | 30 mg AZD1722 bid Receives: Drug: AZD1722 |
| 3 mg od | Experimental | 3 mg AZD1722 od Receives: Drug: AZD1722 |
| 30 mg od | Experimental | 30 mg AZD1722 od Receives: Drug: AZD1722 |
| Placebo | Placebo comparator | Placebo (double dummy technique) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Phosphate Levels
Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment
Measured: End of wash out (pre randomization value) to end of treatment (Day 29)
Secondary outcomes (1)
Change From Baseline in Calcium x Phosphorus Product
Change from baseline (end of wash out) in calcium x phosphorus product
Measured: End of wash out (pre randomization value) to end of treatment (Day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardelyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geoffrey A Block, MD, Principal investigator, Denver Nephrology PC, Denver, CO 80230
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081534
- Sponsor's protocol ID
- D5613C00001
- Status last verified
- Aug 2020
- First submitted
- 6 Mar 2014
- Last updated
- 14 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 38323855Block 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.
PubMed 29617976
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02081534
- Acronym / sponsor ID
- D5613C00001
- Conditions
- Hyperphosphatemia
- Keywords
- S-phosphate, hyperphosphatemia, hemodialysis, ESRD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- ArdelyxIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Posted 14 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 mg bid | Experimental | Drug: AZD17221 mg AZD1722 bid |
| 3 mg bid | Experimental | Drug: AZD17223 mg AZD1722 bid |
| 10 mg bid | Experimental | Drug: AZD172210 mg AZD1722 bid |
| 30 mg bid | Experimental | Drug: AZD172230 mg AZD1722 bid |
| 3 mg od | Experimental | Drug: AZD17223 mg AZD1722 od |
| 30 mg od | Experimental | Drug: AZD172230 mg AZD1722 od |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (double dummy technique) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD1722AZD1722, oral tablet | Drug | 1 mg bid, 10 mg bid, 3 mg bid, 3 mg od, 30 mg bid, 30 mg od |
| PlaceboPlacebo bid, double dummy technique | Drug | Placebo |
Primary outcome
Change in Serum Phosphate Levels
Time frame: End of wash out (pre randomization value) to end of treatment (Day 29)
Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment
1 secondary outcome
Change From Baseline in Calcium x Phosphorus Product
Time frame: End of wash out (pre randomization value) to end of treatment (Day 29)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38323855Sprague 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.
- Derived from this study: PubMed 29617976Block 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.
Related trials for Hyperphosphatemia
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A Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
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RecruitingObservational study
Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
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Recruiting
Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
Kidney Failure, Chronic, Hyperphosphatemia
RecruitingPhase 2
Phosphate in Acute Pancreatitis
Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey A Block, MD principal investigator
Denver Nephrology PC, Denver, CO 80230
41 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD1722 in people with Hyperphosphatemia, run by Ardelyx at 41 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Poland, Slovakia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Phosphate Levels (time frame: End of wash out (pre randomization value) to end of treatment (Day 29)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02081534, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.