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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01750294
First received: December 12, 2012
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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: 12 weeks after intervention ] [ Designated as safety issue: Yes ]

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750294

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

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01750294     History of Changes
Other Study ID Numbers: 1206009002, 1206009002
Study First Received: December 12, 2012
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:
hypertension
kidney disease

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases
Renal Insufficiency
Urologic Diseases
Vascular Diseases
Chlorthalidone
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014