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.
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.
Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine
Drug: Placebo Comparator
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase 1b, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single-Dose of ABT-614 and the Effect of ABT-614 on Glomerular Filtration Rate in Subjects With Type 2 Diabetes and Chronic Kidney Disease With Albuminuria|
- Change in drug concentration [ Time Frame: Day -1 (Baseline) and up to Day 15 ] [ Designated as safety issue: Yes ]Blood and urine tests
- Change in glomerular filtration rate [ Time Frame: Day -1 (Baseline) and up to Day 15 ] [ Designated as safety issue: Yes ]Blood and urine tests
- Change in urinary albumin excretion [ Time Frame: Day -1 (Baseline) and up to Day 15 ] [ Designated as safety issue: Yes ]Urine tests
|Study Start Date:||November 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Other Name: ABT-614
|Placebo Comparator: Placebo Comparator||
Drug: Placebo Comparator
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464320
|United States, Florida|
|Site Reference ID/Investigator# 63442|
|Miami, Florida, United States, 33136|
|Study Director:||Dennis Andress, MD||Renal Global Project Team, Abbott Laboratories|