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

March 2, 2017 updated by: Keryx Biopharmaceuticals

An Open Label Tolerability and Safety Study of KRX-101 (Sulodexide Gelcaps) for the Treatment of Type 2 Diabetic Nephropathic Patients With Persistent Microalbuminuria in Australia, New Zealand, and Hong Kong

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Diabetes is one of the most common causes of end-stage renal disease (ESRD) in the U.S. and in many other developed nations. Despite advances in clinical care, including improvements in glycemic and blood pressure control, the number of new cases of diabetes-related ESRD continues to rise, especially in patients with type 2 diabetes.

The current standard of care for the prevention and treatment of diabetic renal disease includes screening all diabetic patients for microalbuminuria. Patients who test positive for microalbuminuria are then treated with either ACE inhibitors or A2 receptor blockers. Both of these classes of medication have been shown to reduce levels of microalbuminuria in some patient populations. This improvement in microalbuminuria has also shown a delay of progression to a number of other renal function problems, as well as a minimal delay in certain clinical events including ESRD.

Unfortunately, some patients achieve the majority of their therapeutic effect of ACE inhibitors or A2 receptor blockers within the first 6 months of therapy, and many of these patients continue to show persistent microalbuminuria. Therefore, these patients are at an increased risk of progressing to ESRD due to the lack of adequate benefit from their current medication.

Microalbuminuria has a straight-line relationship with adverse renal outcomes; therefore any level of reduction may have clinical benefit. It is reasonable to believe that patients who can reduce or have a complete remission of their microalbuminuria may also lessen the risk of progressing to ESRD. Thus, if KRX-101 is able to cause a reduction or complete remission of microalbuminuria to normoalbuminuria, patients may receive a significant clinical benefit.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

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

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3168
        • Monash Medical Center

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Active or metastatic cancer (note: superficial basal carcinoma of the skin is not an exclusion).
  • 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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sulodexide
Open label extension to original trial
Drug: sulodexide
Other Names:
  • KRX-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observed ACR level from the first visit to the end of study
Time Frame: 1 year
Open label safety extension to assess long-term exposure to sulodexide (KRX-101) in patients with albumin and protein in their urine.
1 year

Collaborators and Investigators

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

Sponsor

Keryx Biopharmaceuticals

Collaborators

Collaborative Study Group (CSG)

Investigators

  • Study Director: Robert Atkins, MD, Monash Medical Centre
  • Principal Investigator: Anne Reutens, MD, Monash Medical Center

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

April 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

April 16, 2007

First Submitted That Met QC Criteria

April 17, 2007

First Posted (Estimate)

April 18, 2007

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRX 101-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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