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.
- Conditions
- Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine
- Interventions
- Drug: Placebo Comparator
- Registration Number
- NCT01464320
- Lead Sponsor
- Abbott
- 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 filtration rate.
- 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 diabetes and CKD (chronic kidney disease) with albuminuria will be selected to participate.
Eighteen subjects will be selected to participate in the Baseline Period to ensure that 16 subjects are enrolled in the Dosing Period. Subjects who are eligible from Screening will be confined to the study site beginning on Day -2 (the day before the Baseline Period infusion). On Day -1, subjects will be administered an iothalamate infusion to measure baseline GFR (glomerular filtration rate). Subjects who continue to be eligible on Day 1 will be randomized in a 1:1 ratio to receive either a 10 mg dose of ABT-614 or matching placebo daily, for 15 days.
On Day 15 subjects will be administered a second iothalamate infusion. Plasma and urine samples for ABT-614 and iothalamate will be collected. Subjects will be released from confinement on Day 20 after the completion of all study procedures including the 120-hour blood sample collection. Thereafter, subjects will return for outpatient visits on Days 25 and 30 as well as 30 days after the last dose of study drug. A ± 2 day window will be permitted on the 30-day Follow-up Visit to accommodate subject scheduling.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABT-614 ABT-614 - Placebo Comparator Placebo Comparator -
- Primary Outcome Measures
Name Time Method Change in drug concentration Day -1 (Baseline) and up to Day 15 Blood and urine tests
Change in glomerular filtration rate Day -1 (Baseline) and up to Day 15 Blood and urine tests
- Secondary Outcome Measures
Name Time Method Change in urinary albumin excretion Day -1 (Baseline) and up to Day 15 Urine tests
Trial Locations
- Locations (1)
Site Reference ID/Investigator# 63442
🇺🇸Miami, Florida, United States