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The purpose of this 264 week study is is to evaluate the efficacy and safety of veverimer in treating adults with moderate-to-severe chronic kidney disease (CKD) and metabolic acidosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veverimer | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veverimer | Drug | Group 1: 9 g veverimer BID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Veverimer by measuring change in serum bicarbonate concentration (SBC) | Visits: Screening to Day 168 | |
| Efficacy of Veverimer in improving physical performance as assessed by the Sit-to-Stand 5 times test (STS5). | Visits: Screening to Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Veverimer in achieving SBC and responder thresholds. | Change from baseline in SBC. Achievement of SBC thresholds (> 4 mmol/L increase from baseline and/or > 23 mmol/L). | Visits: Screening to Day 168 |
| Performance outcomes (PerfO). |
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Inclusion Criteria:
Exclusion Criteria:
Any participant deemed by the Investigator to be an inappropriate candidate for PerfO testing (e.g., severe musculoskeletal pain, non-ambulatory status), inability to complete STS5 without support or with a screening STS5 time < 10 seconds.
History or current diagnosis of:
Ineligible per REVIVE GastroScreen test.
Use of GI polymer binders or sodium zirconium cyclosilicate within 14 days prior to the start of screening or have an expectation to initiate treatment during the study.
Use of acid reducing drugs, including PPIs, H2RAs or P-CABs within 14 days prior to the start of screening or have an expectation to initiate treatment during the study. Very sporadic use (one time per week or less) may be acceptable, as assessed by the Investigator.
Initiation of GLP-1 receptor agonists within 6 months prior to the start of screening, or expectation to initiate use during the study. Participants that have been on a GLP-1 receptor agonist for more than 6 months and have maintained a stable dose and steady body weight for at least one month prior to the start of screening may be considered for enrollment, upon Medical Monitor review. GLP-1 receptor agonists also should not be started during the study.
Participants that are taking any of the following medications and have not been on a stable dose for at least 14 days prior to the start of screening or have an expectation to change dose during the study: diuretics, non-ophthalmic carbonic anhydrase inhibitors, diabetes drugs, RAAS inhibitors, calcium or magnesium supplements, non-polymer phosphate binders, and SGLT-2 inhibitors. These medications also should not be started during the study.
Active, recurrent, or metastatic malignancy at the start of screening.
History of malignancy, except under the following conditions:
Two or more hospitalizations within 12 months prior to the start of screening or a hospitalization within the last 3 months prior to the start of screening due to fluid overload, heart failure, acute kidney injury (AKI) or electrolyte disorders, including hyperkalemia. Participants that have not been hospitalized within the past 3 months and whose condition is stable may be considered for enrollment.
Screening hemoglobin < 9 g/dL.
Low bicarbonate value(s) at time of screening that are due to underlying primary respiratory alkalosis.
Investigational medication administration within 28 days prior to start of screening.
Participants that are taking an average of > 30 units of insulin daily, unless recent (within last 6 months) hemoglobin A1C is < 6.5%.
History of alcoholism or drug/chemical abuse within 1 year prior to the start of screening, in the opinion of the Investigator.
Current, regular use of inhaled/ingested cannabis/THC products.
Inability to take the IP or otherwise comply with the protocol.
Any medical condition, uncontrolled systemic disease or serious concurrent illness that would significantly decrease study compliance or jeopardize the safety of the participant or affect the validity of the trial results, in the opinion of the Investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayla Rasmussen | Contact | 443-569-9228 | arasmussen@renibus.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Institute of Renal Research | Recruiting | Chula Vista | California | 91910 | United States | |
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Subjects will be randomized 2:1 to veverimer or placebo.
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| Drug |
Group 2: 9 g PBO BID |
|
Change in Patient Global Impression of Change of Physical Functioning (PGI-C) Patients answer 1 question: How would you rate your current level of physical functioning (mobility and ability to do everyday physical activities) compared to the beginning of the study? Much better, Moderately better, A little better, No change, A little worse, Moderately worse, Much worse. Lower score is a better outcome.
Change in Patient Global Impressions Scale - Severity (PGI-S) Patients answer 1 question: How would you rate your current level of physical functioning (mobility and ability to do everyday physical activities)? Poor, Fair, Good, Very good, Excellent. Higher score is a better outcome.
| Visits: Screening to Day 168 |
| Frailty and muscle mass assessment. | Change in performance on 6-minute walk test 6MWT. | Visits: Screening to Day 168 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. | Visits: Screening to Day 168 |
| Academic Medical Research Institute |
| Recruiting |
| Los Angeles |
| California |
| 90022 |
| United States |
| UC Davis Health, Dept of Internal Medicine | Recruiting | Sacramento | California | 95817 | United States |
| California Institute of Renal Research - San Diego | Recruiting | San Diego | California | 92111 | United States |
| Renal Research Office, University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
| Velocity Clinical Research | Recruiting | Edgewater | Florida | 32132 | United States |
| Belkis Delgado MD PA | Recruiting | Miami Springs | Florida | 33166 | United States |
| ClinTrial Research - Oakwater | Recruiting | Orlando | Florida | 32806 | United States |
| Southeastern Clinical Research Institute | Recruiting | Augusta | Georgia | 30904 | United States |
| CARE Institute - Boise Kidney | Recruiting | Boise | Idaho | 83706 | United States |
| Idaho Kidney - CARE Institute | Recruiting | Chubbuck | Idaho | 83201 | United States |
| CARE Institute - Idaho Falls | Recruiting | Idaho Falls | Idaho | 83401 | United States |
| Research by Design | Recruiting | Chicago | Illinois | 60643 | United States |
| Indiana University School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Nephrology Associates of Kentuckiana | Recruiting | Louisville | Kentucky | 40205 | United States |
| JCCT-Clinical Research Consultants | Recruiting | Kansas City | Missouri | 64111 | United States |
| New York-Presbyterian Queens | Recruiting | Fresh Meadows | New York | 11365 | United States |
| Brookview Hills Research Associates | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| Texas Center for Kidney Disease Research | Recruiting | Fort Worth | Texas | 76110 | United States |
| Prolato Clinical Research Center | Recruiting | Houston | Texas | 77054 | United States |
| Clinical Advancement Center | Recruiting | San Antonio | Texas | 78212 | United States |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000630913 | veverimer |
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