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

Primary Purpose

Diabetic Nephropathy

Status

Terminated

Phase

Phase 3

Locations

Australia

Study Type

Interventional

Intervention

sulodexide

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetes, Microalbuminuria, Proteinuria, Albuminuria, KRX-101, Sulodexide, Nephropathy, Keryx, Collaborative Study Group, Diabetic nephropathy with persistent microalbuminuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Monash Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sulodexide

Arm Description

Open label extension to original trial

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00462202

First Posted

April 16, 2007

Last Updated

March 2, 2017

Sponsor

Keryx Biopharmaceuticals

Collaborators

Collaborative Study Group (CSG)

1. Study Identification

Unique Protocol Identification Number

NCT00462202

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Why Stopped

Interim analysis of efficacy trial showed no drug efficacy.

Study Start Date

April 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Keryx Biopharmaceuticals

Collaborators

Collaborative Study Group (CSG)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

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

Diabetic Nephropathy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sulodexide

Arm Type

Experimental

Arm Description

Open label extension to original trial

Intervention Type

Drug

Intervention Name(s)

sulodexide

Other Intervention Name(s)

KRX-101

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Atkins, MD

Organizational Affiliation

Monash Medical Centre

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Anne Reutens, MD

Organizational Affiliation

Monash Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Monash Medical Center

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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