Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000406303
Ethics application status
Approved
Date submitted
12/08/2008
Date registered
19/08/2008
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A study using Pyridorin™ to treat people with Nephropathy (Kidney Disease) due to Type 2 Diabetes
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 2b Study to Evaluate the Safety and Efficacy of Pyridorin™ (pyridoxamine dihydrochloride) in Patients With Nephropathy Due to Type 2 Diabetes
Secondary ID [1] 684 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 3544 0
Kidney Disease 3545 0
Condition category
Condition code
Renal and Urogenital 3701 3701 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study treatment is allocated to eligible subjects randomly. Subjects have an equal chance of being allocated to receive Pyridorin 150 mg orally, twice a day (BID) taken for 52 weeks or Pyridorin 300 mg orally BID taken for 52 weeks or placebo taken orally for 52 weeks.
Intervention code [1] 3257 0
Treatment: Drugs
Comparator / control treatment
White opaque Coni-Snap hard gelatin capsules filled with white to off-white powder, taken orally BID, taken for 52 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 4605 0
The primary efficacy variable is Serum Creatinine change from baseline to endpoint. The serum creatinine is measured via subject blood sample analysis.
Timepoint [1] 4605 0
Serum Creatinine is measured in the blood samples drawn from subjects each full visit during the study. Visits typically occur at screening, randomisation (considered day 0), month 1, 3, 6, 9, week 51 and week 52. If the subject enters a run-in period, additional visit may occur to the discretion of the investigator, in order to allow the subject to meet eligibility criteria.
Secondary outcome [1] 7768 0
Serum Creatinine slope. The serum creatinine is measured via subject blood sample analysis.
Timepoint [1] 7768 0
Serum Creatinine is measured in the blood samples drawn from subjects each full visit during the study. Visits typically occur at screening, randomisation (considered day 0), month 1, 3, 6, 9, week 51 and week 52. If the subject enters a run-in period, additional visits may occur to the discretion of the investigator, in order to allow the subject to meet eligibility criteria. Blood samples will also be measured at these visits if applicable.
Secondary outcome [2] 7769 0
24-hour urine protein/creatinine ratio (PCR) change. This is measured by analysing subject urine samples.
Timepoint [2] 7769 0
Measured at screening, month 6 and month 12. If the subject enters a run-in period, additional visits may occur to the discretion of the investigator, in order to allow the subject to meet eligibility criteria. PCR will also be measured at these visits if applicable.
Secondary outcome [3] 7770 0
The safety of Pyridorin compared to placebo, as assessed by adverse events, electrocardiograms (ECGs), seated blood pressure, heart rate, physical examination, body weight, clinical chemistries, glycosylated hemoglobin, and hematology.
Timepoint [3] 7770 0
Different safety parameters are measured at different visits in the study. Blood pressure, heart rate, body weight and Adverse Events are reviewed at each full visit. ECG and physical exams occur twice during the study, whereas certain blood parameters (such as serum chemistry and heamatology) occur three times (around the start, middle and end) during the study.

Eligibility
Key inclusion criteria
Patients who have given voluntary written consent to participate in this study prior to conducting Screening Visit procedures

Women of childbearing potential (WOCBP) who agree to use appropriate birth control (double barrier methods, hormonal contraceptives, or intrauterine device) for the duration of the study (WOCBP is defined as all women who are not surgically sterile or are not at least 1 year post-menopausal). All WOCBP must have a negative serum pregnancy test at the Screening Visit.

At the Screening Visit, ALL patients must have a history of overt diabetic nephropathy.

Patients must be receiving an Angiotensin Cenverting Enzyme Inhibitor (ACE-I) or an Angiotensin Receptor Blocker (ARB), for at least 3 months prior to the Qualifying Visit, where the dose of the ACE-I or the ARB is considered appropriate for that patient and has been stable for at least 2 months.

Patients must be on stable blood pressure medications for 2 months prior to the Qualifying Visit.

Appropriate Serum Creatiine and 24-hour urine PCR results at qualifying visit compared to Screening.
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with type 1 diabetes;

Patients with a diagnosis of chronic renal disease, other than diabetic renal disease, with or without hypertensive renal disease;

Patients receiving a renin inhibitor or an aldosterone antagonist or a combination of an ACE-I and an ARB within 2 months of the Qualifying Visit;

Patients with a history of solid organ transplantation;

Patients with a history of myocardial infarction, coronary re-vascularization procedures (including percutaneous transluminal coronary angioplasty), cerebrovascular accident or transient ischemic attack within 1 month prior to the Screening Visit;

Patients with a diagnosis of Class III or IV congestive heart failure at any time;

Patients with a history of neoplastic disease (except basal or squamous cell carcinoma of the skin) within 5 years prior to the Screening Visit;

Patients with any history of dialysis within 2 years prior to the Screening Visit;

Patients in whom dialysis or renal transplantation is anticipated by their physician within 1 year after the Screening Visit;

Patients who used SCr altering drugs within 1 month prior to the Screening Visit;

Patients who require systemic immunosuppression therapy for >2 weeks (except for inhalant steroids);

Patients with clinically significant liver disease or transaminase (alanine aminotransferase and aspartate aminotransferase) levels >2.5 x upper limit of normal measured at the Screening Visit;

Patients with bilirubin levels >1.5 x upper limit of normal measured at the Screening Visit;

Patients with a history of allergic or other adverse response to vitamin B preparations;

Patients who require >50 mg of vitamin B6 daily;

Patients who have a history of dysphasia and swallowing disorders;

Patients with a history of hypersensitivity to Pyridorin or any of the excipients in the Pyridorin formulation;

Patients who have taken pyridoxamine or any other investigational drug within 30 days prior to the Screening Visit, or have participated in a previous Pyridorin trial or another clinical trial within 30 days prior to the Screening Visit;

Patients with a current history of drug or alcohol abuse;

Patients unlikely to comply with the study protocol (e.g., an inability and unwillingness to participate in adequate training, an uncooperative attitude, inability to return for follow-up visits, or unlikelihood of completing the study);

Women who are lactating, pregnant or intend to become pregnant during the course of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects who meet all inclusion and no exclusion criteria are enrolled via Interactive Vioce Response System (IVRS) to receive Either Pyridorin™ 300mg, Pyridorin™ 150mg or Placebo in a 1:1:1 ratio. Allocation to these treatments is concealed by the central randomisation phone/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is done by the IVRS and is stratified by the Serum Creatinine measurement at the qualifying visit.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1098 0
3168
Recruitment postcode(s) [2] 1099 0
3050
Recruitment postcode(s) [3] 1100 0
3121
Recruitment postcode(s) [4] 1101 0
2050
Recruitment postcode(s) [5] 1102 0
4121
Recruitment postcode(s) [6] 1103 0
2250
Recruitment postcode(s) [7] 1104 0
4029
Recruitment outside Australia
Country [1] 1148 0
Israel
State/province [1] 1148 0
Country [2] 1149 0
United States of America
State/province [2] 1149 0

Funding & Sponsors
Funding source category [1] 3725 0
Commercial sector/Industry
Name [1] 3725 0
NephroGenex, Inc.
Country [1] 3725 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Medpace Australia Pty. Limited
Address
Omnico Business Centre
Suite 1, Building 26
270 Ferntree Gully Rd
NOTTING HILL, VIC. 3168
Country
Australia
Secondary sponsor category [1] 3343 0
None
Name [1] 3343 0
Address [1] 3343 0
Country [1] 3343 0
Other collaborator category [1] 369 0
Other Collaborative groups
Name [1] 369 0
The Collaborative Sutdy Group
Address [1] 369 0
Rush University Medical Center
1653 West Congress Parkway
Chicago, IL 60612
Country [1] 369 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5778 0
Ethics committee address [1] 5778 0
Ethics committee country [1] 5778 0
Date submitted for ethics approval [1] 5778 0
15/08/2008
Approval date [1] 5778 0
Ethics approval number [1] 5778 0

Summary
Brief summary
The primary aim of this project is to determine if the study drug, Pyridorin™, at doses of 150mg orally twice daily or 300mg orally twice daily (compared to placebo), has an effect on the blood values (specifically serum creatinine) of subjects' who have kidney disease from type 2 diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28833 0
Address 28833 0
Country 28833 0
Phone 28833 0
Fax 28833 0
Email 28833 0
Contact person for public queries
Name 11990 0
Dr. Anne Reutens
Address 11990 0
Baker IDI Heart and Diabetes Institute
250 Kooyong Rd.
CAULFIELD, VIC. 3162
Country 11990 0
Australia
Phone 11990 0
+61 3 9258 5050
Fax 11990 0
+61 3 9258 5090
Email 11990 0
Anne.Reutens@med.monash.edu.au
Contact person for scientific queries
Name 2918 0
Professor Robert Atkins
Address 2918 0
Faculty of Nursing, Medicine and Health Sciences
Central and Eastern Clinical School
The Alfred Hospital
89 Commercial Rd.
MELBOURNE, VIC. 3004
Country 2918 0
Australia
Phone 2918 0
+61 3 9903 0178
Fax 2918 0
+61 3 9903 0179
Email 2918 0
bob.atkins@med.monash.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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