Design and Baseline Characteristics of the Chlorthalidone in Chronic Kidney Disease (CLICK) Trial.
Aged
Antihypertensive Agents
/ administration & dosage
Blood Pressure
/ drug effects
Blood Pressure Monitoring, Ambulatory
Chlorthalidone
/ administration & dosage
Diuretics
/ administration & dosage
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
Humans
Hypertension
/ diagnosis
Male
Middle Aged
Renal Insufficiency, Chronic
/ complications
Treatment Outcome
Ambulatory blood pressure monitoring
Chronic kidney disease
Hypertension
Thiazide diuretics
Journal
American journal of nephrology
ISSN: 1421-9670
Titre abrégé: Am J Nephrol
Pays: Switzerland
ID NLM: 8109361
Informations de publication
Date de publication:
2020
2020
Historique:
received:
17
04
2020
accepted:
14
05
2020
pubmed:
15
7
2020
medline:
20
7
2021
entrez:
15
7
2020
Statut:
ppublish
Résumé
Hypertension often accompanies chronic kidney disease (CKD), and diuretics are widely prescribed to reduce blood pressure (BP). Chlorthalidone (CTD) is a thiazide-like diuretic and an effective antihypertensive drug, yet little data exist to support its use in treating hypertension in individuals with advanced CKD. Chlorthalidone in Chronic Kidney Disease (CLICK) is a phase II, single-institution, multicenter, double-blind randomized control trial to test the hypothesis that CTD improves BP, through reduction of extracellular fluid volume, and results in target organ protection in patients with stage 4 CKD and poorly controlled hypertension. After a single-blind placebo run-in for 2 weeks and confirmation of hypertension by 24-h ambulatory blood pressure (ABP), patients are randomized to either placebo or CTD 12.5 mg once daily (QD) followed by dose escalation. Randomization is stratified by prior loop diuretic use, and the double-blind phase lasts 12 weeks. With a total of 160 patients, the study will have ≥80% power to detect a 6 mm Hg difference in systolic 24-h ABP between the 2 treatment groups. Between June 2016 and October 2019, 131 patients have been randomized. The baseline characteristics are as follows: average age 65.8 years, 79% men, 36% Black, 79% with diabetes, mean eGFR 23.2 mL/min/1.73 m2, median urine albumin/creatinine ratio 923 mg/g, average number of BP medications 3.4, 60% on loop diuretics, and 24-h ABP averaged 141.7/73.8 mm Hg. Among patients with stage 4 CKD and uncontrolled hypertension, CLICK should answer the question whether CTD is safe and effective.
Sections du résumé
BACKGROUND
Hypertension often accompanies chronic kidney disease (CKD), and diuretics are widely prescribed to reduce blood pressure (BP). Chlorthalidone (CTD) is a thiazide-like diuretic and an effective antihypertensive drug, yet little data exist to support its use in treating hypertension in individuals with advanced CKD.
METHODS
Chlorthalidone in Chronic Kidney Disease (CLICK) is a phase II, single-institution, multicenter, double-blind randomized control trial to test the hypothesis that CTD improves BP, through reduction of extracellular fluid volume, and results in target organ protection in patients with stage 4 CKD and poorly controlled hypertension. After a single-blind placebo run-in for 2 weeks and confirmation of hypertension by 24-h ambulatory blood pressure (ABP), patients are randomized to either placebo or CTD 12.5 mg once daily (QD) followed by dose escalation. Randomization is stratified by prior loop diuretic use, and the double-blind phase lasts 12 weeks. With a total of 160 patients, the study will have ≥80% power to detect a 6 mm Hg difference in systolic 24-h ABP between the 2 treatment groups.
RESULTS
Between June 2016 and October 2019, 131 patients have been randomized. The baseline characteristics are as follows: average age 65.8 years, 79% men, 36% Black, 79% with diabetes, mean eGFR 23.2 mL/min/1.73 m2, median urine albumin/creatinine ratio 923 mg/g, average number of BP medications 3.4, 60% on loop diuretics, and 24-h ABP averaged 141.7/73.8 mm Hg.
CONCLUSION
Among patients with stage 4 CKD and uncontrolled hypertension, CLICK should answer the question whether CTD is safe and effective.
Identifiants
pubmed: 32663820
pii: 000508700
doi: 10.1159/000508700
pmc: PMC7409874
mid: NIHMS1600604
doi:
Substances chimiques
Antihypertensive Agents
0
Diuretics
0
Chlorthalidone
Q0MQD1073Q
Banques de données
ClinicalTrials.gov
['NCT02841280']
Types de publication
Clinical Trial Protocol
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
542-552Subventions
Organisme : NHLBI NIH HHS
ID : R01 HL126903
Pays : United States
Informations de copyright
© 2020 S. Karger AG, Basel.
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