Does Thiazolidinedione Therapy Improve Endothelial Function and Preserve Renal Function

NCT00586261 | Terminated Results

• 1 other identifier: 06-002245
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of the current proposal is that chronic pioglitazone therapy will result in improved endothelial function, decreased inflammation, and preservation of renal function in patients with CKD but without diabetes.

Conditions

Chronic Kidney Disease

Keywords

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Proteinuria; Albuminuria

Outcome Measures

Primary Outcomes (1)

• Change in Brachial Arterial Reactivity

  Brachial arterial reactivity was measured by ultrasound. A blood pressure cuff was placed around the right forearm. Using the ultrasound probe of the ultrasound, 2-dimensional images clearly defining the anterior and posterior intimal wall of the brachial artery were collected. Flow velocities were then measured using pulsed wave Doppler. The blood pressure cuff previously placed around the patient's right forearm was inflated to 200 mmHg. The cuff remained inflated for 5 minutes as the patient remained motionless and quiet. Prior to deflation, the patient was asked to remain still as flow velocities and 2-dimensional images were obtained immediately following cuff deflation. Then a 0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication and all measurements were repeated.

  After 6 months of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo 30 mg daily for 6 months, nitroglycerin was given to check the brachial reactivity.

Drug: Placebo; Drug: Nitroglycerin

Pioglitazone

ACTIVE COMPARATOR

Pioglitazone 30 mg daily for 6 months, nitroglycerin was given to check the brachial reactivity.

Drug: Pioglitazone; Drug: Nitroglycerin

Interventions

Pioglitazone DRUG

Pioglitazone 30 mg daily for 6 months

Also known as: Actos

Pioglitazone

Placebo DRUG

Placebo 30 mg daily for 6 months

Placebo

Nitroglycerin DRUG

0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication to check the brachial reactivity.

Also known as: Nitrostat

Pioglitazone; Placebo

Eligibility Criteria

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

You may qualify if:

• Age over 18 years.
• Creatinine clearance ≤ 60 ml/min by the Cockcroft-Gault equation
• Patients not anticipated to go on dialysis or have renal transplantation in the next 6 months
• Ability to provide informed consent
• Life expectancy greater than 12 months

You may not qualify if:

• Diabetes mellitus or a fasting blood glucose ≥ 110 mg/dL
• Acute renal failure
• Class 3 or 4 heart failure
• Liver failure, ascites, or an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) two times the upper limit of normal
• Hemoglobin less than 9 mg/dL
• Multiple myeloma
• Premenopausal women not using at least 1 form of birth control
• Pregnant or nursing women
• Prisoners
• Known allergy to pioglitazone

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Proteinuria; Albuminuria

Interventions

Pioglitazone; Nitroglycerin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; 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; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitro Compounds

Limitations and Caveats

The study was stopped early due to low enrollment because of the specifics of the inclusion criteria.

Results Point of Contact

• Title: Dr. Patricia Best
• Organization: Mayo Clinic

best.patricia@mayo.edu

507-284-4441

Study Officials

• Patricia M. Best, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: March 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 15, 2013
• Results First Posted: March 7, 2013

Record last verified: 2013-03

Locations

US (1)