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

This study has been completed.
Information provided by (Responsible Party):
Indiana University Identifier:
First received: December 12, 2012
Last updated: May 10, 2016
Last verified: May 2016
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).

Condition Intervention Phase
Chronic Kidney Disease
Poorly-Controlled Hypertension
Drug: Chlorthalidone
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks [ Time Frame: Baseline and 12 weeks after intervention ]

Enrollment: 14
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01750294

United States, Indiana
Richard L. Roudebush VAMC
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Principal Investigator: Rajiv Agarwal, MD FASN FAHA Indiana University
  More Information

Responsible Party: Indiana University Identifier: NCT01750294     History of Changes
Other Study ID Numbers: 1206009002
1206009002 ( Other Identifier: IRB )
Study First Received: December 12, 2012
Results First Received: April 6, 2016
Last Updated: May 10, 2016

Keywords provided by Indiana University:
kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on March 27, 2017