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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01464320
First received: November 1, 2011
Last updated: August 21, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine
Drug: ABT-614
Drug: Placebo Comparator
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Change in urinary albumin excretion [ Time Frame: Day -1 (Baseline) and up to Day 15 ] [ Designated as safety issue: Yes ]
    Urine tests


Enrollment: 16
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-614 Drug: ABT-614
Active
Other Name: ABT-614
Placebo Comparator: Placebo Comparator Drug: Placebo Comparator
Placebo

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.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Male or female aged between 19 and 70 years, inclusive, at time of consent.
  2. Type 2 diabetes receiving at least one anti-diabetic medication for at least one year at the time of Screening.
  3. Hemoglobin A1c < 12% at the time of Screening.
  4. Estimated glomerular filtration rate ≥ 30 mL/min calculated by the Cockcroft-Gault Formula at the time of Screening.
  5. Urinary albumin to creatinine ratio 100 to 5000 mg/g creatinine at the time of Screening.

Exclusion Criteria

  1. History of unusual or allergic reaction to iodine, to products containing iodine (for example., iodine containing foods) or to other radio-opaque agents.
  2. Subject history of epileptic seizures or convulsions.
  3. 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.
  4. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, potential hydrogen (pH) or absorption.
  5. Clinically significant respiratory (except mild asthma), gastrointestinal, hematologic, neurologic, thyroid or any uncontrolled medical illness or psychiatric disease or disorder.
  6. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464320

Locations
United States, Florida
Site Reference ID/Investigator# 63442
Miami, Florida, United States, 33136
Sponsors and Collaborators
Abbott
Investigators
Study Director: Dennis Andress, MD Renal Global Project Team, Abbott Laboratories
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01464320     History of Changes
Other Study ID Numbers: M13-107
Study First Received: November 1, 2011
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Safety
Type 2 diabetes
Kidney disease

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 18, 2014