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

NCT01750294 | Completed Phase 4 Results DMC

• 1 other identifier: 1206009002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Kidney Disease; Poorly-Controlled Hypertension

Keywords

hypertension; kidney disease

Outcome Measures

Primary Outcomes (1)

• Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks

  Baseline and 12 weeks after intervention

Interventions

Chlorthalidone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Richard L. Roudebush VAMC

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Kidney Diseases

Interventions

Chlorthalidone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Rajiv Agarwal, MD, FAHA, FASN, FASH
• Organization: Indiana University & Richard L Roudebush VA Medical Center

ragarwal@iu.edu

317-988-2241

Study Officials

• Rajiv Agarwal, MD FASN FAHA

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 13, 2016
• Results First Posted: May 10, 2016

Record last verified: 2016-05

Locations

US (1)