Chronic Kidney Disease Requiring Chronic DialysisPhase 4OPTIMIZENCT04549597
Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia
A Phase 4 study testing Tenapanor in people with Chronic Kidney Disease Requiring Chronic Dialysis and Hyperphosphatemia, run by Ardelyx at 1 site in United States.
Trial summary
This is a randomized, open-label study to evaluate different methods of initiating tenapanor therapy in CKD patients on dialysis with hyperphosphatemia, when they are either phosphate binder naïve or on phosphate binder therapy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis, Hyperphosphatemia
- What is being tested?
- Tenapanor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 1 Dec 2021
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form prior to any study specific procedures.
- Males or females aged 18 to 80 years, inclusive, at Screening (Visit 1).
- Females must be non-pregnant and non-lactating.
- Patients on phosphate binder therapy must be on chronic maintenance hemodialysis (HD) 3 times per week for at least 3 months or chronic maintenance peritoneal dialysis (PD) for a minimum of 6 months. If modality of dialysis has changed, the patient must meet one of the two dialysis criteria above and been on the new modality of dialysis for a minimum of one month. Phosphate binder naïve patients must be on chronic maintenance HD 3 times per week or chronic maintenance PD.
- Kt/V ≥1.2 at most recent measurement prior to Screening (Visit 1).
- Prescribed and taking phosphate binder medication at least 3 times per day or being phosphate binder naïve; defined as having not taken phosphate binders for at least 3 months prior to Screening. The patient must be taking a minimum of 6 pills per day for Renvela, Auryxia, or PhosLo; and/or a minimum of 3 pills per day for Fosrenol or Velphoro.
Show all 9Show fewer
- For patients taking phosphate binders, both the s-P level at the most recent measurement prior to Screening (Visit 1) and the s-P level at Screening (Visit 1) must be >5.5 and ≤10.0 mg/dL.
- For phosphate binder naïve patients, the s-P level at Screening (Visit 1) must be >4.5 and ≤10.0 mg/dL.
- Able to understand and comply with the protocol.
Who cannot join
- Severe hyperphosphatemia defined as having an s-P level >10.0 mg/dL at any time point during routine clinical monitoring for the 3 preceding months before Screening (Visit 1).
- Serum/plasma PTH >1200 pg/mL. The most recent value from the patient's medical records should be used.
- Clinical signs of hypovolemia at Screening (Visit 1) as judged by the Investigator.
- History of inflammatory bowel disease or irritable bowel syndrome with diarrhea.
- Scheduled for living donor kidney transplant or plans to relocate to another center during the study.
- Use of an investigational agent within 30 days prior to Screening (Visit 1).
- Involvement in the planning and/or conduct of the study (applies to both Ardelyx/Contract Research Organization (CRO) staff and/or staff at the study site).
- If, in the opinion of the Investigator, the patient is unable or unwilling to fulfill the requirements of the protocol or has a condition which would render the results uninterpretable.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Florida Research Institute
Lauderdale Lakes, Florida, 33313
About this study
Official title: Randomized Open-Label Study to Evaluate Tenapanor as the Core Therapy in the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Who Are Phosphate Binder Naive or on Phosphate Binders to Optimize Phosphorus Management
This is a randomized, open-label study to evaluate different methods of initiating tenapanor therapy in CKD patients on dialysis with hyperphosphatemia, when they are either phosphate binder naïve or on phosphate binder therapy. The objective to evaluate the effect of tenapanor alone or in combination with phosphate binders to achieve target serum phosphorus (s-P) levels of ≤5.5 mg/dL when tenapanor is administered as the core therapy (alone or in combination with phosphate binders) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
Read the detailed description
Approximately 330 CKD patients on dialysis with hyperphosphatemia (>4.5 mg/dL) will be enrolled in this study.
This is a randomized, open-label study to evaluate different methods of initiating tenapanor therapy in CKD patients on dialysis with hyperphosphatemia, when they are either phosphate binder naïve or on phosphate binder therapy.
The study consists of a Screening visit and a 10-week open-label Treatment Period (TP), for which
- Patients with s-P >5.5 and ≤10.0 mg/dL under stable phosphate binder treatment are randomized in a 1:1 ratio to two different treatment cohorts:
- Cohort 1 (straight switch), which stops taking phosphate binders and is started on tenapanor 30 mg twice daily (BID) at Visit 2 (Day 1);
- Cohort 2, which decreases phosphate binder dose by at least 50% (may be more than 50% if patient is taking an odd number of binder pills each day), with ability to switch the binder regimen from thrice daily (TID) to BID or QD; and initiates tenapanor 30 mg BID at Visit 2 (Day 1).
- Phosphate binder naïve patients with s-P >4.5 and ≤10.0 mg/dL are enrolled as Cohort 3 and receive tenapanor at Visit 2 (Day 1) with a starting dose of 30 mg BID.
- Patients on phosphate binder therapy must receive phosphate binder(s) thrice daily, and both the s-P level assessed at the most recent measurement prior to the Screening visit (Visit 1) and the s-P level assessed at the Screening visit (Visit 1) must be >5.5 and ≤10.0 mg/dL to qualify for randomization into Cohort 1 or Cohort 2 at Visit 2 (Day 1).
- Phosphate binder naïve patients must have the s-P level assessed at the Screening visit (Visit 1) >4.5 and ≤10.0 mg/dL to qualify for enrollment into Cohort 3 at Visit 2 (Day 1).
Patients who do not meet the randomization/enrollment criteria on s-P will be discontinued as screen failures.
During the TP, patients will receive tenapanor starting at a dose of 30 mg twice daily. Tenapanor will be taken twice daily; just prior to breakfast and dinner. The Investigator may titrate the dose of tenapanor in 10 mg increments down to a minimum of 10 mg QD or up to a maximum of 30 mg BID at any time during the study based on s-P levels and/or gastrointestinal (GI) tolerability.
- Being tested
- Tenapanor
- Keywords
- hyperphosphatemia
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenapanorDrug
Use of tenapanor
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Straight Switch | Experimental | Patients stop taking phosphate binders and start tenapanor 30 mg twice daily Receives: Drug: Tenapanor |
| Cohort 2: Decrease Phosphate Binder by 50% | Experimental | Decreases phosphate binder dose by at least 50% with the ability to switch the binder regiment from thrice daily (TID) to BID or once a day and initiates tenapanor 30 mg BID Receives: Drug: Tenapanor |
| Cohort 3: Phosphate Binder Naive | Experimental | Phosphate binder naive patients are enrolled as Cohort 3 and receive tenapanor with a starting dose of 30 mg/BID Receives: Drug: Tenapanor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Tenapanor to Achieve Target s-P Levels of Less Than or Equal to 5.5 mg/dL
To evaluate the effect of tenapanor alone or in combination with phosphate binders to achieve target serum phosphorus (s-P) levels of ≤5.5 mg/dL when tenapanor is administered as the core therapy for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
Measured: 10 weeks
Secondary outcomes (2)
To Evaluate the Effect of Tenapanor to Achieve Various s-P Levels ≤4.5 mg/dL
Evaluating the ability of different treatment regimens to lower s-P to different levels
Measured: 10 weeks
To Evaluate the Effect of Tenapanor on Reducing Daily Phosphorus-lowering Therapy Pill Burden.
Evaluating the ability of tenapanor to make the phosphate lowering treatment regimen better for patients by evaluating the change in pill weight or pill number from baseline to the end of the 10-week treatment period.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start20 Nov 2020
- Primary completion13 Oct 2021
- Study completion1 Dec 2021
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 Chronic Kidney Disease Requiring Chronic DialysisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardelyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549597
- Sponsor's protocol ID
- TEN-02-402
- Acronym
- OPTIMIZE
- Status last verified
- Mar 2023
- First submitted
- 9 Sep 2020
- Last updated
- 29 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 38323855Silva AL, Chertow GM, Hernandez GT, Lynn RI, Tietjen DP, Rosenbaum DP, Yang Y, Edelstein S. Tenapanor Improves Long-Term Control of Hyperphosphatemia in Patients Receiving Maintenance Dialysis: the NORMALIZE Study. Kidney360. 2023 Nov 1;4(11):1580-1589. doi: 10.34067/KID.0000000000000280. Epub 2023 Oct 19.
PubMed 37853560
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-Label Study to Evaluate Tenapanor as the Core Therapy in the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Who Are Phosphate Binder Naive or on Phosphate Binders to Optimize Phosphorus Management
- ClinicalTrials.gov ID
- NCT04549597
- Acronym / sponsor ID
- OPTIMIZE / TEN-02-402
- Keywords
- hyperphosphatemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- ArdelyxIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Posted 29 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label study to evaluate different methods of initiating tenapanor therapy in CKD patients on dialysis with hyperphosphatemia, when they are either phosphate binder naïve or on phosphate binder therapy. The objective to evaluate the effect of tenapanor alone or in combination with phosphate binders to achieve target serum phosphorus (s-P) levels of ≤5.5 mg/dL when tenapanor is administered as the core therapy (alone or in combination with phosphate binders) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
Detailed description
Approximately 330 CKD patients on dialysis with hyperphosphatemia (>4.5 mg/dL) will be enrolled in this study.
This is a randomized, open-label study to evaluate different methods of initiating tenapanor therapy in CKD patients on dialysis with hyperphosphatemia, when they are either phosphate binder naïve or on phosphate binder therapy.
The study consists of a Screening visit and a 10-week open-label Treatment Period (TP), for which
- Patients with s-P >5.5 and ≤10.0 mg/dL under stable phosphate binder treatment are randomized in a 1:1 ratio to two different treatment cohorts:
- Cohort 1 (straight switch), which stops taking phosphate binders and is started on tenapanor 30 mg twice daily (BID) at Visit 2 (Day 1);
- Cohort 2, which decreases phosphate binder dose by at least 50% (may be more than 50% if patient is taking an odd number of binder pills each day), with ability to switch the binder regimen from thrice daily (TID) to BID or QD; and initiates tenapanor 30 mg BID at Visit 2 (Day 1).
- Phosphate binder naïve patients with s-P >4.5 and ≤10.0 mg/dL are enrolled as Cohort 3 and receive tenapanor at Visit 2 (Day 1) with a starting dose of 30 mg BID.
- Patients on phosphate binder therapy must receive phosphate binder(s) thrice daily, and both the s-P level assessed at the most recent measurement prior to the Screening visit (Visit 1) and the s-P level assessed at the Screening visit (Visit 1) must be >5.5 and ≤10.0 mg/dL to qualify for randomization into Cohort 1 or Cohort 2 at Visit 2 (Day 1).
- Phosphate binder naïve patients must have the s-P level assessed at the Screening visit (Visit 1) >4.5 and ≤10.0 mg/dL to qualify for enrollment into Cohort 3 at Visit 2 (Day 1).
Patients who do not meet the randomization/enrollment criteria on s-P will be discontinued as screen failures.
During the TP, patients will receive tenapanor starting at a dose of 30 mg twice daily. Tenapanor will be taken twice daily; just prior to breakfast and dinner. The Investigator may titrate the dose of tenapanor in 10 mg increments down to a minimum of 10 mg QD or up to a maximum of 30 mg BID at any time during the study based on s-P levels and/or gastrointestinal (GI) tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Straight Switch | Experimental | Drug: TenapanorPatients stop taking phosphate binders and start tenapanor 30 mg twice daily |
| Cohort 2: Decrease Phosphate Binder by 50% | Experimental | Drug: TenapanorDecreases phosphate binder dose by at least 50% with the ability to switch the binder regiment from thrice daily (TID) to BID or once a day and initiates tenapanor 30 mg BID |
| Cohort 3: Phosphate Binder Naive | Experimental | Drug: TenapanorPhosphate binder naive patients are enrolled as Cohort 3 and receive tenapanor with a starting dose of 30 mg/BID |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent form prior to any study specific procedures.
- Males or females aged 18 to 80 years, inclusive, at Screening (Visit 1).
- Females must be non-pregnant and non-lactating.
- Patients on phosphate binder therapy must be on chronic maintenance hemodialysis (HD) 3 times per week for at least 3 months or chronic maintenance peritoneal dialysis (PD) for a minimum of 6 months. If modality of dialysis has changed, the patient must meet one of the two dialysis criteria above and been on the new modality of dialysis for a minimum of one month. Phosphate binder naïve patients must be on chronic maintenance HD 3 times per week or chronic maintenance PD.
- Kt/V ≥1.2 at most recent measurement prior to Screening (Visit 1).
Key exclusion criteria (8 listed)
- Severe hyperphosphatemia defined as having an s-P level >10.0 mg/dL at any time point during routine clinical monitoring for the 3 preceding months before Screening (Visit 1).
- Serum/plasma PTH >1200 pg/mL. The most recent value from the patient's medical records should be used.
- Clinical signs of hypovolemia at Screening (Visit 1) as judged by the Investigator.
- History of inflammatory bowel disease or irritable bowel syndrome with diarrhea.
- Scheduled for living donor kidney transplant or plans to relocate to another center during the study.
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 |
|---|---|---|
| TenapanorUse of tenapanor | Drug | Cohort 1: Straight Switch, Cohort 2: Decrease Phosphate Binder by 50%, Cohort 3: Phosphate Binder Naive |
Primary outcome
Effect of Tenapanor to Achieve Target s-P Levels of Less Than or Equal to 5.5 mg/dL
Time frame: 10 weeks
To evaluate the effect of tenapanor alone or in combination with phosphate binders to achieve target serum phosphorus (s-P) levels of ≤5.5 mg/dL when tenapanor is administered as the core therapy for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
2 secondary outcomes
To Evaluate the Effect of Tenapanor to Achieve Various s-P Levels ≤4.5 mg/dL
Time frame: 10 weeks
To Evaluate the Effect of Tenapanor on Reducing Daily Phosphorus-lowering Therapy Pill Burden.
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- 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 37853560Silva AL, Chertow GM, Hernandez GT, Lynn RI, Tietjen DP, Rosenbaum DP, Yang Y, Edelstein S. Tenapanor Improves Long-Term Control of Hyperphosphatemia in Patients Receiving Maintenance Dialysis: the NORMALIZE Study. Kidney360. 2023 Nov 1;4(11):1580-1589. doi: 10.34067/KID.0000000000000280. Epub 2023 Oct 19.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease Requiring Chronic Dialysis
Recruiting
DIALysis With EXpanded Solute Removal
Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD)
RecruitingPhase 2
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis
Recruiting
Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients
Chronic Kidney Disease Requiring Hemodialysis
Recruiting
Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)
Chronic Kidney Disease (CKD) Stage 5, Kidney Dysfunction Requiring Dialysis (KDRD)
Recruiting
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
Kidney Disease, End-Stage, End-stage Renal Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenapanor in people with Chronic Kidney Disease Requiring Chronic Dialysis and Hyperphosphatemia, run by Ardelyx at 1 site in United States.
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 9 inclusion and 8 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 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 29 Mar 2023). 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?
Effect of Tenapanor to Achieve Target s-P Levels of Less Than or Equal to 5.5 mg/dL (time frame: 10 weeks). 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 NCT04549597, 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 29 Mar 2023.