A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03018067 |
Recruitment Status :
Terminated
(Sponsor stopped program])
First Posted : January 11, 2017
Last Update Posted : December 26, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperkalemia | Drug: RDX227675 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia |
Actual Study Start Date : | January 2017 |
Actual Primary Completion Date : | May 2017 |
Actual Study Completion Date : | May 2017 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
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.
|
Drug: Placebo |
Experimental: 10 g qd
RDX227675, 10 g qd
|
Drug: RDX227675 |
Experimental: 20 g qd
RDX227675, 20 g qd
|
Drug: RDX227675 |
Experimental: 30 g qd
RDX227675, 30 g qd
|
Drug: RDX227675 |
- Exponential Rate of Change in Serum Potassium from Baseline [ Time Frame: 48 hours ]Onset of Action
- Change in Serum Potassium Levels [ Time Frame: 7 days ]
- Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 7 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018067
United States, North Carolina | |
Capital Nephrology Associates, PA | |
Cary, North Carolina, United States, 27511 |
Study Chair: | David P Rosenbaum, Ph.D. | Ardelyx, Inc. |
Responsible Party: | Ardelyx |
ClinicalTrials.gov Identifier: | NCT03018067 |
Other Study ID Numbers: |
RDX227675-201 |
First Posted: | January 11, 2017 Key Record Dates |
Last Update Posted: | December 26, 2019 |
Last Verified: | December 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Hyperkalemia Water-Electrolyte Imbalance Metabolic Diseases |