HyperphosphatemiaPhase 2/3NCT03824587
Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy
A Phase 2/3 study testing Tenapanor and Phosphate Binder Agents in people with Hyperphosphatemia, run by Ardelyx at 48 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- Tenapanor and Phosphate Binder Agents
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 48 sitesUnited States
- Study dates
- 28 Feb 2019to 17 Jul 2019
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent prior to any study specific procedures.
- Males or females aged 18 to 80 years, inclusive, at Screening
- Females must be non-pregnant, non-lactating and either be post-menopausal for at least -2 months, have documentation of irreversible surgical sterilization, use of acceptable -contraceptive method, or sexual abstinence, or a sterile sexual partner from Screening -until 30 days after the last subject visit.
- Males must agree to avoid fathering a child (or donating sperm), and therefore be either sterile (documented) or agree to use approved methods of contraception, from the time of enrollment until 30 days after end of study.
- Chronic maintenance hemodialysis (HD) 3x/week for at least 3 months or chronic maintenance peritoneal dialysis (PD) for a minimum of 6 months.
- If receiving active vitamin D or calcimimetics, the dose should have been unchanged for the last 4 weeks prior to Screening.
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- Kt/V ≥1.2 at most recent measurement prior to Screening.
- Prescribed and taking phosphate binder medication at least 3 times per day, and the prescribed dose should have been unchanged during the last 4 weeks prior to Screening.
- Serum phosphorus levels must be ≥5.5 and ≤10.0 mg/dL at Screening and the end of the run-in period, analyzed at the central laboratory used in the study.
Who cannot join
- Severe hyperphosphatemia defined as having an s-P level >10.0 mg/dL on phosphate-binders at any time point during routine clinical monitoring for the 3 preceding months before Screening.
- Serum/plasma parathyroid hormone >1200 pg/mL.
- Clinical signs of hypovolemia at Screening as judged by the Investigator.
- History of inflammatory bowel disease (IBD) or irritable bowel syndrome with diarrhea (IBS-D).
- Scheduled for living donor kidney transplant or plans to relocate to another center during the study period.
- Use of an investigational agent within 30 days prior to Screening.
- 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 subject 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
48 sites in 1 country.
48 sites in 1 country
United States48 sites
Dialysis Clinic, Inc - Albany GA
Albany, Georgia, 31701
Renal Medicine Associates
Albuquerque, New Mexico, 87109
Mountain Kidney and Hypertension Associates
Asheville, North Carolina, 28801
Mountain Kidney & Hypertension Associates, P.A.
Asheville, North Carolina, 28805
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
Southeast Renal Research
Beverly Hills, California, 90211
Dialysis Clinic, Inc - Boston/Somerville
Boston, Massachusetts, 02111
Nova Clinical Research, LLC
Bradenton, Florida, 34209
Boise Kidney & Hypertension, PLLC - Meridian
Caldwell, Idaho, 83605
California Institute of Renal Research - Chula Vista
Chula Vista, California, 91910
University of Cincinnati (UC) - Department of Nephrology
Cincinnati, Ohio, 45267
Columbia Nephrology Associates, P.A.
Columbia, South Carolina, 29203
Horizon Research Group - Coral Gables
Coral Gables, Florida, 33134
Durham Nephrology Associates
Durham, North Carolina, 27704
U.S. Renal Care - Gallup
Gallup, New Mexico, 87301
Northwell Health
Great Neck, New York, 11021
Med Center Dialysis
Houston, Texas, 77004
Nephrology Consultants, LLC
Huntsville, Alabama, 35805
Paragon Health PC - Nephrology Center
Kalamazoo, Michigan, 49007
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111
Dialysis Clinic, Inc - Kansas City
Kansas City, Missouri, 64131
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, 37923
Kidney Specialists of Southern Nevada
Las Vegas, Nevada, 89107
South Florida Research Institute
Lauderdale Lakes, Florida, 33313
North America Research Institute
Lynwood, California, 90262
US Renal Care - Waxahachie
Mansfield, Texas, 76063
US Renal Care - Mesquite
Mesquite, Texas, 75150
Total Research Group, LLC
Miami, Florida, 33126
InterMed Consultants
Minneapolis, Minnesota, 55404
DaVita Clinical Research - Santa Fe Spring
Montebello, California, 90640
Dialysis Clinic, Inc - North Brunswick
North Brunswick, New Jersey, 08902
South Carolina Nephrology & Hypertension Center Inc.
Orangeburg, South Carolina, 29118
Omega Research Consultants, LLC
Orlando, Florida, 32810
US Renal Care Pine Bluff
Pine Bluff, Arkansas, 71603
Sierra Nevada Nephrology Consultants
Reno, Nevada, 89511
Central Coast Nephrology
Salinas, California, 93901
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212
US Renal Care - Pleasanton Road
San Antonio, Texas, 78221
US Renal Care - Westover Hills
San Antonio, Texas, 78251
North America Research Institute - San Dimas
San Dimas, California, 91773
DCI - Spartanburg
Spartanburg, South Carolina, 29301
Polack Renal, LLC (SMO)
St Louis, Missouri, 63121
Genesis Clinical Trials
Tampa, Florida, 33614
Nephrology and Hypertension Associates, LTD
Tupelo, Mississippi, 38801
Chabot Nephrology Medical Group
Union City, California, 94587
American Institute of Research
Whittier, California, 90603
Southeastern Nephrology Associates - Wilmington
Wilmington, North Carolina, 28401
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy in End-Stage Renal Disease (ESRD) Subjects With Hyperphosphatemia
This is a randomized, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy.
Read the detailed description
The study consists of a Screening visit; a Run-in Period of at least 2 weeks and up to 4 weeks, where existing phosphate binder treatment is maintained; and a 4-week Double-Blind Treatment Period.
At Screening, a subject must be on thrice daily phosphate binder therapy and have a serum phosphate (s-P) level ≥5.5 and ≤10.0 mg/dL to qualify for entering the study. s-P will be measured at each visit during the run-in period to enable the evaluation of the s-P randomization criteria.
Subjects who qualify to enroll in the study will be randomized in a 1:1 ratio to receive tenapanor or placebo while continuing their existing phosphate binder treatment.
During the Double-Blind Treatment Period, subjects will receive tenapanor or placebo starting at a dose of 30 mg bid
- Conditions
- Hyperphosphatemia
- Being tested
- Tenapanor, Placebo, Phosphate Binder Agents
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenapanorDrug
Active Drug
PlaceboDrug
Inactive Drug
Phosphate Binder AgentsDrug
Also called sevelamer carbonate, ferric citrate, calcium carbonate, calcium acetate
standard of care phosphate binder use at study entry was maintained throughout the entire study
| Study group | Role | What they receive |
|---|---|---|
| Tenapanor 30 mg BID | Experimental | During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time).
Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period. Receives: Drug: Tenapanor; Drug: Phosphate Binder Agents |
| Placebo | Placebo comparator | same size, weight and appearance of experimental drug Receives: Drug: Placebo; Drug: Phosphate Binder Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.
Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.
Measured: 4 Weeks (28 days randomization period; from baseline to week 4)
Secondary outcomes (3)
s-P Response at Week 4
Achieving an s-P level <5.5 mg/dL
Measured: 4 Weeks (28 days randomization period)
Relative Change From Baseline in iFGF23 at Week 4
iFGF23 at Week 4/baseline iFGF23 - 1
Measured: 4 Weeks (28 days randomization period)
Relative Change From Baseline in cFGF23 at Week 4
cFGF23 at Week 4/baseline cFGF23 - 1
Measured: 4 Weeks (28 days randomization period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start28 Feb 2019
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardelyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David P Rosenbaum, PhD, Study chair, Ardelyx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824587
- Sponsor's protocol ID
- TEN-02-202
- Status last verified
- Feb 2023
- First submitted
- 29 Jan 2019
- Last updated
- 6 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 38323855Pergola PE, Rosenbaum DP, Yang Y, Chertow GM. A Randomized Trial of Tenapanor and Phosphate Binders as a Dual-Mechanism Treatment for Hyperphosphatemia in Patients on Maintenance Dialysis (AMPLIFY). J Am Soc Nephrol. 2021 Jun 1;32(6):1465-1473. doi: 10.1681/ASN.2020101398. Epub 2021 Mar 25.
PubMed 33766811
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy in End-Stage Renal Disease (ESRD) Subjects With Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT03824587
- Acronym / sponsor ID
- TEN-02-202
- Conditions
- Hyperphosphatemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- ArdelyxIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 6 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, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy.
Detailed description
The study consists of a Screening visit; a Run-in Period of at least 2 weeks and up to 4 weeks, where existing phosphate binder treatment is maintained; and a 4-week Double-Blind Treatment Period.
At Screening, a subject must be on thrice daily phosphate binder therapy and have a serum phosphate (s-P) level ≥5.5 and ≤10.0 mg/dL to qualify for entering the study. s-P will be measured at each visit during the run-in period to enable the evaluation of the s-P randomization criteria.
Subjects who qualify to enroll in the study will be randomized in a 1:1 ratio to receive tenapanor or placebo while continuing their existing phosphate binder treatment.
During the Double-Blind Treatment Period, subjects will receive tenapanor or placebo starting at a dose of 30 mg bid
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenapanor 30 mg BID | Experimental | Drug: Tenapanor, Drug: Phosphate Binder AgentsDuring the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time). Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Phosphate Binder Agentssame size, weight and appearance of experimental drug |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent prior to any study specific procedures.
- Males or females aged 18 to 80 years, inclusive, at Screening
- Females must be non-pregnant, non-lactating and either be post-menopausal for at least -2 months, have documentation of irreversible surgical sterilization, use of acceptable -contraceptive method, or sexual abstinence, or a sterile sexual partner from Screening -until 30 days after the last subject visit.
- Males must agree to avoid fathering a child (or donating sperm), and therefore be either sterile (documented) or agree to use approved methods of contraception, from the time of enrollment until 30 days after end of study.
- Chronic maintenance hemodialysis (HD) 3x/week for at least 3 months or chronic maintenance peritoneal dialysis (PD) for a minimum of 6 months.
Key exclusion criteria (8 listed)
- Severe hyperphosphatemia defined as having an s-P level >10.0 mg/dL on phosphate-binders at any time point during routine clinical monitoring for the 3 preceding months before Screening.
- Serum/plasma parathyroid hormone >1200 pg/mL.
- Clinical signs of hypovolemia at Screening as judged by the Investigator.
- History of inflammatory bowel disease (IBD) or irritable bowel syndrome with diarrhea (IBS-D).
- Scheduled for living donor kidney transplant or plans to relocate to another center during the study period.
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 |
|---|---|---|
| TenapanorActive Drug | Drug | Tenapanor 30 mg BID |
| PlaceboInactive Drug | Drug | Placebo |
| Phosphate Binder AgentsAlso: sevelamer carbonate, ferric citrate, calcium carbonate, calcium acetatestandard of care phosphate binder use at study entry was maintained throughout the entire study | Drug | Placebo, Tenapanor 30 mg BID |
Primary outcome
Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.
Time frame: 4 Weeks (28 days randomization period; from baseline to week 4)
Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.
3 secondary outcomes
s-P Response at Week 4
Time frame: 4 Weeks (28 days randomization period)
Relative Change From Baseline in iFGF23 at Week 4
Time frame: 4 Weeks (28 days randomization period)
Relative Change From Baseline in cFGF23 at Week 4
Time frame: 4 Weeks (28 days randomization period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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 33766811Pergola PE, Rosenbaum DP, Yang Y, Chertow GM. A Randomized Trial of Tenapanor and Phosphate Binders as a Dual-Mechanism Treatment for Hyperphosphatemia in Patients on Maintenance Dialysis (AMPLIFY). J Am Soc Nephrol. 2021 Jun 1;32(6):1465-1473. doi: 10.1681/ASN.2020101398. Epub 2021 Mar 25.
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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.
David P Rosenbaum, PhD study chair
Ardelyx
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tenapanor and Phosphate Binder Agents in people with Hyperphosphatemia, run by Ardelyx at 48 sites 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 6 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 48 sites 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. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 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?
Change in Serum Phosphorus (s-P) Level From Baseline to Week 4. (time frame: 4 Weeks (28 days randomization period; from baseline to week 4)). 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 NCT03824587, 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 6 Mar 2023.