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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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12 December 2020 |
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Main ID: |
NCT03390842 |
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Date of registration:
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28/12/2017 |
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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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Long-term Safety Extension to Study TRCA-301
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Scientific title:
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A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis |
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Date of first enrolment:
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December 20, 2017 |
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Target sample size:
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196 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03390842 |
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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: Triple (Participant, Care Provider, Investigator).
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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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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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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Completed the 12-week treatment period and attended the Week 12 Visit in the parent
study TRCA-301.
- Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study
TRCA-301.
Key Exclusion Criteria:
- Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the
Investigator, requires emergency intervention or evaluation for an acute acidotic
process.
- Required dialysis for acute kidney injury or worsening CKD during the parent study
TRCA-301.
- Planned initiation of renal replacement therapy within 6 months following study entry.
- History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing
disorders, severe gastrointestinal disorders, inflammatory bowel disease, major
gastrointestinal surgery, or active gastric/duodenal ulcers.
- Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.
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: TRC101
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Drug: Placebo
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Primary Outcome(s)
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Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to withdrawal.
[Time Frame: From Week 12 (enrollment) to Week 54 (last follow-up visit).]
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Secondary Outcome(s)
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Change from baseline in blood bicarbonate.
[Time Frame: Week 52 (end of treatment)]
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Secondary ID(s)
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TRCA-301E
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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