Status:
COMPLETED
A Study to Evaluate the Safety and Tolerability of ABT-614 and Its Effect on Kidney Function in Subjects With Type 2 Diabetes and Chronic Kidney Disease With Protein in Their Urine.
Lead Sponsor:
Abbott
Conditions:
Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine
Eligibility:
All Genders
19-70 years
Phase:
PHASE1
Brief Summary
To assess the safety, tolerability and pharmacokinetics of ABT-614 in subjects with type 2 diabetes and chronic kidney disease with albuminuria and to determine whether ABT-614 reduces glomerular filt...
Detailed Description
This Phase 1b, single-site, double-blind, randomized, placebo-controlled study will be conducted in three Periods; Baseline, Dosing and Outpatient. Eligible adult male and female subjects with type 2 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female aged between 19 and 70 years, inclusive, at time of consent.
- Type 2 diabetes receiving at least one anti-diabetic medication for at least one year at the time of Screening.
- Hemoglobin A1c \< 12% at the time of Screening.
- Estimated glomerular filtration rate ≥ 30 mL/min calculated by the Cockcroft-Gault Formula at the time of Screening.
- Urinary albumin to creatinine ratio 100 to 5000 mg/g creatinine at the time of Screening.
- Exclusion Criteria
- History of unusual or allergic reaction to iodine, to products containing iodine (for example., iodine containing foods) or to other radio-opaque agents.
- Subject history of epileptic seizures or convulsions.
- Clinically significant cardiac disease or family history of long-QT syndrome and/or subject and/or family history of unexplained, sudden cardiac death. History of myocardial infarction or coronary artery bypass graft is not exclusionary if occurrence is ≥ 12 months prior to the administration of study drug and the subject does not have conduction abnormality and has been stable without intervention, symptoms of ischemia or an increase in cardiovascular medications. Electrocardiography (ECG) should be compared with historical to ensure no new clinically significant changes have occurred.
- History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, potential hydrogen (pH) or absorption.
- Clinically significant respiratory (except mild asthma), gastrointestinal, hematologic, neurologic, thyroid or any uncontrolled medical illness or psychiatric disease or disorder.
- Screening ECG with clinically significant abnormalities and/or confirmed Screening QTcF prolongation more than 430 milliseconds for males and 450 milliseconds for females or ECG with second or third degree atrioventricular block.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01464320
Start Date
November 1 2011
End Date
April 1 2012
Last Update
August 22 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Site Reference ID/Investigator# 63442
Miami, Florida, United States, 33136