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

Chronic Kidney Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750294
• Other study ID #: 1206009002
• Secondary ID: 1206009002
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2012
• Last updated: September 26, 2014
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 monitoring.

• 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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Poorly-Controlled Hypertension
• Renal Insufficiency, Chronic

Intervention

Drug:
• Chlorthalidone

Locations

Country	Name	City	State
United States	Richard L. Roudebush VAMC	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of systolic ambulatory blood pressure from baseline to 12 weeks		12 weeks after intervention	Yes