Chlorthalidone in Chronic Kidney Disease (CLICK)
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ClinicalTrials.gov Identifier: NCT02841280 |
Recruitment Status :
Recruiting
First Posted : July 22, 2016
Last Update Posted : January 24, 2019
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Condition or disease | Intervention/treatment | Phase |
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Renal Insufficiency, Chronic Hypertension | Drug: Chlorthalidone Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Study Start Date : | July 2016 |
Estimated Primary Completion Date : | January 2021 |
Estimated Study Completion Date : | January 2022 |

Arm | Intervention/treatment |
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Experimental: Chlorthalidone
Subjects with stage 4 chronic kidney disease (CKD) and poorly controlled hypertension confirmed by 24 hour ambulatory blood pressure monitoring will be randomized into two groups, one receiving placebo and one receiving a diuretic called chlorthalidone (12.5 mg at randomization). Doubling of the dose of the diuretic (up to 50 mg) or placebo will occur every 4 weeks if required by home blood pressure (BP) results.
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Drug: Chlorthalidone
This is a forced-titration study and the study drug or placebo will be increased if goal BP is not achieved (dosage of chlorthalidone not to exceed 50 mg) |
Placebo Comparator: Placebo
Subjects with stage 4 CKD and poorly controlled hypertension confirmed by 24 hour ambulatory blood pressure monitoring will be randomized into two groups, one receiving placebo and one receiving a diuretic called chlorthalidone (12.5 mg at randomization). Doubling of the dose of the diuretic (up to 50 mg) or placebo will occur every 4 weeks if required by home BP results.
|
Drug: Placebo
This is a forced-titration study and the study drug or placebo will be increased if goal BP is not achieved (dosage of chlorthalidone not to exceed 50 mg) |
- Change from baseline to 12 weeks in systolic ambulatory blood pressure in the chlorthalidone group compared to placebo. [ Time Frame: Baseline to 12 weeks ]
- Changes in albuminuria from baseline at each 4 week visit in the log transformed albumin/creatinine ratio in the chlorthalidone group compared to placebo, as measured by overnight urine collection. [ Time Frame: Baseline to 12 weeks ]
- Change from baseline at each 4 week visit in log of aldosterone to renin ratio in the chlorthalidone group compared to placebo. No adjustments will be made for multiple comparisons. [ Time Frame: Baseline to 12 weeks ]
- Change from baseline at each 4 week visit in log of B-type natriuretic peptide in the chlorthalidone group compared to placebo. No adjustments will be made for multiple comparisons. [ Time Frame: Baseline to 12 weeks ]
- Change from baseline at each 4 week visit in body volume in the chlorthalidone group compared to placebo. No adjustments will be made for multiple comparisons. [ Time Frame: Baseline to 12 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age greater than 18 years.
- Calculated glomerular filtration rate (GFR) by 4-component Modification of Diet in Renal Disease (MDRD) formula < 30 ml/min/1.73m2 but ≥15 mL/min/1.73m2. The hospital laboratory uses isotope dilution mass spectrometry (IDMS) calibrated creatinine and the appropriate formula is used to estimate GFR.
- Hypertension. This is defined as BP of either ≥130 systolic or ≥80 mmHg by 24-hour ambulatory BP monitoring.
- Treatment with antihypertensive drugs: This would require the use of at least one antihypertensive drug. One of the drugs should be either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). If these are contraindicated then use of a beta-blocker is required prior to randomization.
Exclusion Criteria:
- Use of thiazide or thiazide-like drugs in the previous 12 weeks.
- Use of furosemide in a dose >200 mg/d.
- BP of either ≥160 systolic or ≥100 mmHg by 24-hour ambulatory BP monitoring.
- Expected to receive renal replacement therapy within the next 3 months.
- Myocardial infarction, heart failure hospitalization, or stroke ≤3 months prior to randomization.
- Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable).
- Known hypersensitivity to thiazide or sulfa drugs.
- Organ transplant recipient or therapy with immunosuppressive agents.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841280
Contact: Rajiv Agarwal, MD | 317-988-2241 | ragarwal@iu.edu | |
Contact: William B Rogers, BS | 317-988-3024 | rogersbe@iu.edu |
United States, Indiana | |
Indiana University School of Medicine, Division of Nephrology | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Rajiv Agarwal, MD 317-988-2241 ragarwal@iu.edu | |
Contact: William Rogers, BS 317-988-3024 rogersbe@iu.edu | |
Principal Investigator: Rajiv Agarwal, MD |
Principal Investigator: | Rajiv Agarwal, MD | Indiana University |
Responsible Party: | Rajiv Agarwal, Professor of Medicine, Indiana University |
ClinicalTrials.gov Identifier: | NCT02841280 History of Changes |
Other Study ID Numbers: |
1507540384 |
First Posted: | July 22, 2016 Key Record Dates |
Last Update Posted: | January 24, 2019 |
Last Verified: | January 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Chlorthalidone Antihypertensive Agents |
Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |