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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 May 2021 |
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Main ID: |
NCT03317444 |
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Date of registration:
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11/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
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Scientific title:
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A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis |
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Date of first enrolment:
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September 26, 2017 |
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Target sample size:
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217 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03317444 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Bulgaria
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Croatia
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Georgia
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Hungary
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Serbia
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Slovenia
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Ukraine
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United States
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Contacts
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Name:
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Clinical Operations |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tricida, Inc. |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Blood bicarbonate level of 12 to 20 mEq/L.
- Estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.73m2.
- Stable kidney function defined as <=20% variability in eGFR during screening period.
Key Exclusion Criteria:
- Any level of low blood bicarbonate during the screening period that in the opinion of
the Investigator, requires emergency intervention or evaluation for an acute acidotic
process.
- Anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within
3 months prior to screening.
- Heart failure with maximum New York Heart Association (NYHA) Class IV symptoms or that
required hospitalization during the preceding 6 months.
- Heart or kidney transplant.
- Chronic obstructive pulmonary disease (COPD) that is treated with chronic oral
steroids, that requires the subject to be on oxygen, or that required hospitalization
within the previous 6 months.
- Change in doses to alkali therapy in the 4 weeks prior to screening.
- History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing
disorders, inflammatory bowel disease, major gastrointestinal surgery, frequent
diarrhea or active gastric/duodenal ulcers.
- Serum calcium <= 8.0 mg/dL at screening.
- Planned initiation of renal replacement therapy within 12 weeks following
randomization.
- Use of polymeric binder drugs within 14 days prior to screening.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Metabolic Acidosis
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Intervention(s)
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Drug: Placebo
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Drug: TRC101
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Primary Outcome(s)
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Subjects With Change From Baseline in Serum Bicarbonate of = 4 mEq/L or Serum Bicarbonate Within the Normal Range
[Time Frame: Baseline to Week 12]
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Secondary Outcome(s)
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Change From Baseline to End of Treatment in Serum Bicarbonate
[Time Frame: Baseline to Week 12]
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Secondary ID(s)
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TRCA-301
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2016-003825-41
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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