Open Label Tolerability and Safety Study of KRX-101 in Australia, New Zealand, and Hong Kong

NCT00462202 | Terminated Phase 3 DMC

• 1 other identifier: KRX 101-302
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the tolerability and safety of KRX-101 in treating persistent microalbuminuria in type 2 diabetic patients who are also being treated with stable, maximum tolerated doses of either ACE inhibitors or A2 receptor blockers.

Conditions

Diabetic Nephropathy

Keywords

Diabetes; Microalbuminuria; Proteinuria; Albuminuria; KRX-101; Sulodexide; Nephropathy; Keryx; Collaborative Study Group; Diabetic nephropathy with persistent microalbuminuria

Outcome Measures

Primary Outcomes (1)

• Observed ACR level from the first visit to the end of study

  Open label safety extension to assess long-term exposure to sulodexide (KRX-101) in patients with albumin and protein in their urine.

  1 year

Study Arms (1)

Sulodexide

EXPERIMENTAL

Open label extension to original trial

Drug: sulodexide

Interventions

sulodexide DRUG

Also known as: KRX-101

Sulodexide

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age and has successfully completed Keryx Study 101-301.
• Diagnosis of DM2 based on ADA criteria.
• Continued stable seated systolic blood pressure \< 150 mmHg and diastolic blood pressure \< 90 mmHg.
• Provide written informed consent to participate in the study.
• If female and of childbearing potential, must continue to be willing to use adequate contraception, as determined by the investigator, for the duration of the study.

You may not qualify if:

• Evidence of hepatic dysfunction including total bilirubin \> 2.0 mg/dL (34 micromol/L) or liver enzymes \> 3 times upper limit of normal.
• Unstable angina pectoris or New York Heart Association Class III or IV congestive heart failure.
• A history of any major medical condition, including but not limited to: aortic aneurysm; myocardial infarction, stroke, or other cardiovascular events in the past 3 months; gastrointestinal bleeding in the past 3 months; HIV; and other medical conditions deemed serious by the investigator. Active Hepatitis B or C (currently active disease defined as an abnormal liver biopsy or persistent, elevated transaminases, SGOT, SGPT).
• Any risk of bleeding, including a history of bleeding diathesis and a platelet count \< 100,000/mm³.
• Anticipated surgery within trial period.
• History of noncompliance to medical regimens in Keryx Study No.101-301.
• Participation in any experimental drug study in the past 60 days, except for KRX-101-301, prior to entry into the study, or plan to participate in any experimental drug study during the study period.
• Lactation, pregnancy, or an anticipated or planned pregnancy during the study period.
• Known allergy or intolerance to any heparin-like compounds.
• Patients with other specific renal diseases known to be the cause of nephropathy, and patients with other specific, clinically significant renal disease.
• Inability to give an informed consent or cooperate with the study personnel.

Sponsors & Collaborators

• Keryx Biopharmaceuticals: lead
• Collaborative Study Group (CSG): collaborator

Study Sites (1)

Monash Medical Center

Melbourne, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus; Proteinuria; Albuminuria; Kidney Diseases

Interventions

glucuronyl glucosamine glycan sulfate

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Atkins, MD

  Monash Medical Centre

  STUDY DIRECTOR

• Anne Reutens, MD

  Monash Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)