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

This study has been terminated.
(Interim analysis of efficacy trial showed no drug efficacy.)
Sponsor:
Collaborator:
Collaborative Study Group (CSG)
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00462202
First received: April 16, 2007
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Diabetic Nephropathy
Drug: sulodexide
Drug: Sulodexide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Keryx Biopharmaceuticals:

Primary Outcome Measures:
  • Observed ACR level from the first visit to the end of study [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Open label safety extension to assess long-term exposure to sulodexide (KRX-101) in patients with albumin and protein in their urine.


Enrollment: 200
Study Start Date: April 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sulodexide
Open label extension to original trial
Drug: sulodexide
N/A
Other Name: KRX-101
Drug: Sulodexide
N/A
Other Name: KRX-101

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462202

Locations
Australia, Victoria
Monash Medical Center
Melbourne, Victoria, Australia, 3168
Sponsors and Collaborators
Keryx Biopharmaceuticals
Collaborative Study Group (CSG)
Investigators
Study Director: Robert Atkins, MD Monash Medical Centre
Principal Investigator: Anne Reutens, MD Monash Medical Center
  More Information

No publications provided

Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00462202     History of Changes
Other Study ID Numbers: KRX 101-302
Study First Received: April 16, 2007
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration
Australia: Human Research Ethics Committee
New Zealand: Medsafe
Hong Kong: Department of Health

Keywords provided by Keryx Biopharmaceuticals:
Diabetes
Microalbuminuria
Proteinuria
Albuminuria
KRX-101
Sulodexide
Nephropathy
Keryx
Collaborative Study Group
Diabetic nephropathy with persistent microalbuminuria

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014