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Tests treatment safety and results for CKD
Official title A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis
ClinicalTrials.gov ID: NCT07355062
What this study is testing
What is Veverimer?
Veverimer is an investigational medicine, being studied as a potential treatment for ckd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have provided written informed consent prior to participation in the study.
- Male or female participants 18 years of age or older.
- Diagnosed with CKD (eGFR \< 60 mL/min/1.73m2) and not expected to require renal replacement therapy (dialysis or kidney transplant) throughout the...
- Within 6 months prior to screening have at least two SBC between 12 and 20 mmol/L, inclusive. If only one historical SBC is available, a second SBC...
- Within screening period have two central laboratory SBC (at least 24 hours apart and more than 4 hours after food) between 12 and 21 mmol/L...
You likely can't join if
- Any participant deemed by the Investigator to be an inappropriate candidate for PerfO testing (e.g., severe musculoskeletal pain, non-ambulatory...
- History or current diagnosis of:
- Clinically significant gastroparesis or a history of bariatric surgery.
- Bowel obstruction, swallowing disorders, severe gastrointestinal disorders, including inflammatory bowel disease, major gastrointestinal surgery...
- Severe recurrent diarrhea or constipation, as assessed by the Investigator.
- Pernicious anemia, atrophic or autoimmune gastritis, achlorhydria or hypochlorhydria.
See the full eligibility criteria
- Have provided written informed consent prior to participation in the study.
- Male or female participants 18 years of age or older.
- Diagnosed with CKD (eGFR \< 60 mL/min/1.73m2) and not expected to require renal replacement therapy (dialysis or kidney transplant) throughout the duration of the study.
- Within 6 months prior to screening have at least two SBC between 12 and 20 mmol/L, inclusive. If only one historical SBC is available, a second SBC may be drawn on screening visit S1 and analyzed by the local laboratory.
- Within screening period have two central laboratory SBC (at least 24 hours apart and more than 4 hours after food) between 12 and 21 mmol/L, inclusive.
- Willing to keep food consumption similar to baseline throughout the entire study.
- If taking oral alkali therapy, dose has been stable for at least 28 days prior to the start of screening and is expected to remain stable throughout the study.
- Women who are of childbearing potential must have a negative pregnancy test and agree to abstinence or to use contraception.
- 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...
- History or current diagnosis of:
- Clinically significant gastroparesis or a history of bariatric surgery.
- Bowel obstruction, swallowing disorders, severe gastrointestinal disorders, including inflammatory bowel disease, major gastrointestinal surgery including gastrectomy, or known active gastric/duodenal ulcers.
- Severe recurrent diarrhea or constipation, as assessed by the Investigator.
- Pernicious anemia, atrophic or autoimmune gastritis, achlorhydria or hypochlorhydria.
- 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...
- 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...
- 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...
- Active, recurrent, or metastatic malignancy at the start of screening.
- History of malignancy, except under the following conditions:
- Carcinoma in situ (e.g., of the cervix, breast, or bladder) that has been completely excised and shows no evidence of residual disease.
- Non-melanoma skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma) that have been completely excised and show no evidence of recurrence.
- Low grade prostate cancer, in the opinion of the Investigator (i.e., no metastasis, Gleason score \ 6 months prior to the screening visit.
- Any other malignancy that was treated with curative intent and has been in complete remission for ≥ 5 years prior to the screening visit.
- 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)...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chula Vista, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Edgewater, Florida, United States
- Miami Springs, Florida, United States
- Orlando, Florida, United States
- Augusta, Georgia, United States
- Boise, Idaho, United States
- Chubbuck, Idaho, United States
- Idaho Falls, Idaho, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Kansas City, Missouri, United States
- Fresh Meadows, New York, United States
- Winston-Salem, North Carolina, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chula Vista, California, United States; Los Angeles, California, United States; Sacramento, California, United States; San Diego, California, United States; Aurora, Colorado, United States; Edgewater, Florida, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.