Back to results

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.

Primary Purpose

Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ABT-614

Placebo Comparator

About this trial

This is an interventional treatment trial for Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine focused on measuring Safety, Type 2 diabetes, Kidney disease

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Site Reference ID/Investigator# 63442

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ABT-614

Placebo Comparator

Arm Description

Outcomes

Primary Outcome Measures

Change in drug concentration

Blood and urine tests

Change in glomerular filtration rate

Blood and urine tests

Secondary Outcome Measures

Change in urinary albumin excretion

Urine tests

Full Information

NCT ID

NCT01464320

First Posted

November 1, 2011

Last Updated

August 21, 2012

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT01464320

Brief Title

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.

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine

Keywords

Safety, Type 2 diabetes, Kidney disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABT-614

Arm Type

Experimental

Arm Title

Placebo Comparator

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ABT-614

Intervention Description

Active

Intervention Type

Drug

Intervention Name(s)

Placebo Comparator

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change in drug concentration

Description

Blood and urine tests

Time Frame

Day -1 (Baseline) and up to Day 15

Title

Change in glomerular filtration rate

Description

Blood and urine tests

Time Frame

Day -1 (Baseline) and up to Day 15

Secondary Outcome Measure Information:

Title

Change in urinary albumin excretion

Description

Urine tests

Time Frame

Day -1 (Baseline) and up to Day 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dennis Andress, MD

Organizational Affiliation

Renal Global Project Team, Abbott Laboratories

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 63442

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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.

We'll reach out to this number within 24 hrs