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NCT02841280 · ClinicalTrials.gov registry record · Phase 2
Chlorthalidone in Chronic Kidney Disease
A Phase 2 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT02841280 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 160 participants.
The verdict
NCT02841280, a Phase 2 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study Summary
It is estimated that in the United States there are approximately 8 million individuals who have moderate to severe chronic kidney disease (CKD). Among them hypertension is common and is often poorly controlled due to an expanded volume state; diuretics are frequently prescribed. Loop diuretics are potent and effective in lowering blood pressure (BP) but their use is associated with acute kidney injury. Thiazide diuretics, on the other hand, are less potent, their use may be associated with less acute kidney injury, but as yet there are no firm data to support that thiazide diuretic therapy can improve BP among subjects with advanced CKD. The investigators found 13 studies on the use of thiazide diuretics in advanced CKD either alone or in combination with loop diuretics and concluded that thiazides may be useful. Thiazides cause a negative Na balance, increase Na excretion by 10-15% and weight loss by 1-2 kg in observational studies. Observational data show that thiazides lead to an improvement in seated clinic BP of about 10-15 mmHg systolic and 5-10 mmHg diastolic whereas randomized trials show about a 15 mmHg reduction in mean BP. Randomized trials had only between 7 and 23 subjects each; accordingly, larger studies are needed to evaluate their safety and efficacy in moderate to advanced CKD.
Interventions
- DRUG Placebo
- DRUG Chlorthalidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2016-07 |
| Est. Completion | 2021-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02841280
The ClinicalTrials.gov registry entry for NCT02841280 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02841280 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02841280 about?
NCT02841280 is a clinical study titled "Chlorthalidone in Chronic Kidney Disease". It is estimated that in the United States there are approximately 8 million individuals who have moderate to severe chronic kidney disease (CKD). Among them hypertension is common and is often poorly controlled due to an expanded volume state; diuretics are frequently prescribed. Loop diuretics are ...
What is the current status of trial NCT02841280?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2016-07. Estimated completion is 2021-04.
What interventions are being tested in trial NCT02841280?
The interventions under investigation include: Placebo (DRUG), Chlorthalidone (DRUG).
Who is sponsoring clinical trial NCT02841280?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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