HyperkalemiaPhase 2NCT03018067
A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
A Phase 2 study testing RDX227675 in people with Hyperkalemia, run by Ardelyx at 1 site in United States.
Trial summary
This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action, safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify are randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675 10 g qd), Group 3 (RDX227675 20 g qd), Group 4… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- RDX227675
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 18 to 85 years old, inclusive
- Two consecutive i-STAT K values ≥ 5.5 to < 6.5 mmol/L, measured a minimum of 60-minutes apart within 1 day of first RDX227675 dose on Day 1 (prior to randomization)
- i-STAT K value ≥ 5.5 to < 6.5 mmol/L on Day 1 (prior to randomization)
- Ability to have repeated blood draws or effective venous catheterization
- Females of child bearing potential must have negative urine pregnancy test on Day 1 (prior to randomization)
- Females but be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods
- Males must agree to use an appropriate method of contraception or have documented surgical sterilization
Who cannot join
- Pseudohyperkalemia signs and symptoms
- Treatment with K lowering drugs, within 7 days prior to randomization
- Uncontrolled Type 2 diabetes, as defined as most recent historical HbA1c > 10%, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months
- Diabetic ketoacidosis
- Known hypersensitivity to polystyrene sulfonate
- Significant cardiovascular or cerebrovascular events in the past 2 months
Show all 10Show fewer
- Severe heart failure, defined as NYHA (New York Heart Association) class IV or hospitalization to treat heart failure in previous 3 months
- History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders, or major gastrointestinal surgery
- Major psychiatric disorder (DSM-III-R or DSM-IV) including major depression or other psychoses that has required hospitalization in the last 3 years. History of attempted suicide or uncontrolled bipolar disorder.
- Use of an investigational product within 30 days prior to Screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Capital Nephrology Associates, PA
Cary, North Carolina, 27511
About this study
Official title: A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action, safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify are randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675 10 g qd), Group 3 (RDX227675 20 g qd), Group 4 (RDX227675 30 g qd).
Read the detailed description
The study consists of a screening visit, a 7-day treatment period, and a 7-day treatment-free follow-up period.
- Conditions
- Hyperkalemia
- Being tested
- RDX227675, Placebo
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDX227675Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Microcrystalline Cellulose (MCC), 2 g qd. Subjects assigned to the Placebo group will be randomly assigned in a 1:1:1 ratio to receive either one, two, or three bottles of drug per day. Receives: Drug: Placebo |
| 10 g qd | Experimental | RDX227675, 10 g qd Receives: Drug: RDX227675 |
| 20 g qd | Experimental | RDX227675, 20 g qd Receives: Drug: RDX227675 |
| 30 g qd | Experimental | RDX227675, 30 g qd Receives: Drug: RDX227675 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exponential Rate of Change in Serum Potassium from Baseline
Onset of Action
Measured: 48 hours
Secondary outcomes (2)
Change in Serum Potassium Levels
Measured: 7 days
Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability]
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Sponsor stopped program\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ardelyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David P Rosenbaum, Ph.D., Study chair, Ardelyx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018067
- Sponsor's protocol ID
- RDX227675-201
- Status last verified
- Dec 2019
- First submitted
- 10 Jan 2017
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
- ClinicalTrials.gov ID
- NCT03018067
- Acronym / sponsor ID
- RDX227675-201
- Conditions
- Hyperkalemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor stopped program\]
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ArdelyxIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action, safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify are randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675 10 g qd), Group 3 (RDX227675 20 g qd), Group 4 (RDX227675 30 g qd).
Detailed description
The study consists of a screening visit, a 7-day treatment period, and a 7-day treatment-free follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMicrocrystalline Cellulose (MCC), 2 g qd. Subjects assigned to the Placebo group will be randomly assigned in a 1:1:1 ratio to receive either one, two, or three bottles of drug per day. |
| 10 g qd | Experimental | Drug: RDX227675RDX227675, 10 g qd |
| 20 g qd | Experimental | Drug: RDX227675RDX227675, 20 g qd |
| 30 g qd | Experimental | Drug: RDX227675RDX227675, 30 g qd |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 85 years old, inclusive
- Two consecutive i-STAT K values ≥ 5.5 to < 6.5 mmol/L, measured a minimum of 60-minutes apart within 1 day of first RDX227675 dose on Day 1 (prior to randomization)
- i-STAT K value ≥ 5.5 to < 6.5 mmol/L on Day 1 (prior to randomization)
- Ability to have repeated blood draws or effective venous catheterization
- Females of child bearing potential must have negative urine pregnancy test on Day 1 (prior to randomization)
Key exclusion criteria (10 listed)
- Pseudohyperkalemia signs and symptoms
- Treatment with K lowering drugs, within 7 days prior to randomization
- Uncontrolled Type 2 diabetes, as defined as most recent historical HbA1c > 10%, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months
- Diabetic ketoacidosis
- Known hypersensitivity to polystyrene sulfonate
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 |
|---|---|---|
| RDX227675 | Drug | 10 g qd, 20 g qd, 30 g qd |
| Placebo | Drug | Placebo |
Primary outcome
Exponential Rate of Change in Serum Potassium from Baseline
Time frame: 48 hours
Onset of Action
2 secondary outcomes
Change in Serum Potassium Levels
Time frame: 7 days
Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability]
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Sponsor stopped program\]). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Hyperkalemia
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
RecruitingPhase 3
A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Hyperkalemia
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
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, Ph.D. study chair
Ardelyx, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RDX227675 in people with Hyperkalemia, 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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 Dec 2019. 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. 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?
The study was stopped early (reason given: Sponsor stopped program\]). Results are not available in the source record.
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?
Exponential Rate of Change in Serum Potassium from Baseline (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2019.