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A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease; Poorly-Controlled Hypertension

Intervention: Chlorthalidone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Indiana University

Official(s) and/or principal investigator(s):
Rajiv Agarwal, MD FASN FAHA, Principal Investigator, Affiliation: Indiana University


It is estimated that in the United States there are approximately 8 million individuals with moderate to severe chronic kidney disease (CKD), not on dialysis. Volume expansion plays an important role in the pathogenesis of hypertension in patients with CKD. For this pilot study, the investigators hypothesize that administration of chlorthalidone among patients with moderate to severe CKD will improve BP.

Clinical Details

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change of systolic ambulatory blood pressure from baseline to 12 weeks


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Age greater than 18 years.

- eGFR ≤ 45 ml/min/1. 73m2 but ≥20 mL/min/1. 73m2.

- Poorly controlled blood pressure by 24-hour ambulatory BP monitoring.

- Treated hypertension: use of at least one antihypertensive drug. One of the drugs

should be either an ACE inhibitor or angiotensin receptor blocker. If these are contraindicated then use of a beta-blocker is required. Exclusion Criteria:

- Use of thiazide or thiazide-like drugs in the previous 3 months.

- Use of furosemide in a dose >200 mg/d.

- Ambulatory BP of either ≥160 systolic or ≥100 mmHg by 24-hour ambulatory BP


- Expected to receive renal replacement therapy within the next 3 months.

- Vascular event such as myocardial infarction, heart failure hospitalization, or

stroke within 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. Nasal or inhaled

corticosteroids will be permitted.

Locations and Contacts

Richard L. Roudebush VAMC, Indianapolis, Indiana 46202, United States
Additional Information

Starting date: August 2012
Last updated: September 26, 2014

Page last updated: August 23, 2015

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