Back to resultsA Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD
Primary Purpose
Chronic Kidney Disease, Poorly-Controlled Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chlorthalidone
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring hypertension, kidney disease
Eligibility Criteria
Inclusion Criteria:
- Age greater than 18 years.
- Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 but ≥20 mL/min/1.73m2.
- Poorly controlled blood pressure by 24-hour ambulatory blood pressure (BP) monitoring.
- Treated hypertension: 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.
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.
Sites / Locations
- Richard L. Roudebush VAMC
Outcomes
Primary Outcome Measures
Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01750294
Brief Title
A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 blood pressure (BP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Poorly-Controlled Hypertension
Keywords
hypertension, kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Chlorthalidone
Primary Outcome Measure Information:
Title
Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks
Time Frame
Baseline and 12 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age greater than 18 years.
Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 but ≥20 mL/min/1.73m2.
Poorly controlled blood pressure by 24-hour ambulatory blood pressure (BP) monitoring.
Treated hypertension: 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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajiv Agarwal, MD FASN FAHA
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L. Roudebush VAMC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD
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