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.

August 21, 2012 updated by: Abbott

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Site Reference ID/Investigator# 63442

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Comparator
Drug: Placebo Comparator
Placebo
Experimental: ABT-614
Drug: ABT-614
Active

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in drug concentration
Time Frame: Day -1 (Baseline) and up to Day 15
Blood and urine tests
Day -1 (Baseline) and up to Day 15
Change in glomerular filtration rate
Time Frame: Day -1 (Baseline) and up to Day 15
Blood and urine tests
Day -1 (Baseline) and up to Day 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in urinary albumin excretion
Time Frame: Day -1 (Baseline) and up to Day 15
Urine tests
Day -1 (Baseline) and up to Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dennis Andress, MD, Renal Global Project Team, Abbott Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M13-107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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