Text Size

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

This study is currently recruiting participants.
Verified December 2012 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01750294
First received: December 12, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 12
Study Start Date: August 2012
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750294

Contacts
Contact: Maria Pappas 3179884591 pappas2@iupui.edu

Locations
United States, Indiana
Richard L. Roudebush VAMC Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Maria Pappas     317-988-4591     pappas2@iupui.edu    
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: December 13, 2012
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
Kidney Failure, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Chlorthalidone
Sodium Chloride Symporter Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013