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.

NCT01464320 | Completed Phase 1

• 1 other identifier: M13-107
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine

Keywords

Safety; Type 2 diabetes; Kidney disease

Outcome Measures

Primary Outcomes (2)

• Change in drug concentration

  Blood and urine tests

  Day -1 (Baseline) and up to Day 15

• Change in glomerular filtration rate

  Blood and urine tests

  Day -1 (Baseline) and up to Day 15

Secondary Outcomes (1)

• Change in urinary albumin excretion

  Day -1 (Baseline) and up to Day 15

Study Arms (2)

ABT-614

EXPERIMENTAL

Drug: ABT-614

Placebo Comparator

PLACEBO COMPARATOR

Drug: Placebo Comparator

Interventions

ABT-614 DRUG

Active

ABT-614

Placebo Comparator DRUG

Placebo

Placebo Comparator

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Site Reference ID/Investigator# 63442

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria; Diabetes Mellitus, Type 2; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dennis Andress, MD

  Renal Global Project Team, Abbott Laboratories

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 3, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 22, 2012

Record last verified: 2012-04

Locations

US (1)