Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000959875
Ethics application status
Approved
Date submitted
31/08/2012
Date registered
6/09/2012
Date last updated
6/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inhibition of Fructosamine Oxidase in Diabetic Nephropathy (INFO-Renal) Study
Scientific title
Study to assess whether treatment with GC811007 would arrest the decline in renal function and the associated progression of diabetic retinopathy, peripheral neuropathy and autonomic neuropathy in patients with Type 2 diabetes mellitus.
Secondary ID [1] 279993 0
NIL
Universal Trial Number (UTN)
Trial acronym
INFO-RENAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with type 2 diabetic nephropathy 285901 0
Condition category
Condition code
Metabolic and Endocrine 286092 286092 0 0
Diabetes
Renal and Urogenital 286093 286093 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was a randomized, double-blind, Placebo-controlled study in adult patients with diabetic nephropathy. Upon completion of screening, Enrolment and a 3-week Placebo-run-in period, patients were randomized to treatment with 1200 mg/day, GC811007 (taken as two 300-mg capsules twice daily, BID, before meals) or Placebo, administered as 2 identical 300-mg capsules taken orally twice daily (BID) before meals for 6 months. Patients underwent safety and efficacy assessments during clinic visits at Months 0, 2, 4, and 6. Telephone follow-up interviews were conducted 2 weeks after the final clinic visit.
Intervention code [1] 284319 0
Treatment: Drugs
Comparator / control treatment
Placebo: The Placebo formulation was matched to the active drug in appearance and capsule weight dosage, and was supplied as microcrystalline cellulose (Vivapur type 102) in opaque Capsugel gelatin capsules.
Control group
Placebo

Outcomes
Primary outcome [1] 286568 0
Rate of decline from Baseline to Month 6 in renal function as measured by glomerular filtration rate using 3 calculation methods for creatinine clearance: (i) measured serum and urine creatinine; (ii) Cockcroft-Gault equation based on actual body weight, (iii) Cockcroft-Gault equation based on ideal body weight.
Timepoint [1] 286568 0
Safety and efficacy assessments during clinic visits at Months 0, 2, 4, and 6 when urine collection occurred, for creatinine analysis
Secondary outcome [1] 296185 0
Change in rate of progression of diabetic retinopathy and/or diabetic maculopathy over a 6 month period, as measured by non-mydriatic retinal photography
Timepoint [1] 296185 0
During clinic visits at Months 0, 2, 4, and 6
Secondary outcome [2] 296186 0
Change in rate of progression of peripheral neuropathy over a 6 month period, as measured by change in severity assessed by the Michigan Peripheral Neuropathy Screening Instrument
Timepoint [2] 296186 0
During clinic visits at Months 0, 2, 4, and 6
Secondary outcome [3] 296187 0
Change in severity of autonomic neuropathy as assessed by heart rate variation with deep breathing, upon standing, and during Valsalva manoeuver, as well as postural fall in systolic blood pressure
Timepoint [3] 296187 0
During clinic visits at Months 0, 2, 4, and 6

Eligibility
Key inclusion criteria
Men and women between 30 to 70 years of age with poor blood glucose control, retinopathy and nephropathy resulting from Type 2 diabetes mellitus.
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Healthy volunteers excluded, and those with with poor blood glucose control, retinopathy and nephropathy resulting from Type 2 diabetes mellitus, but outside of the age range above

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)
This was a randomized, double-blind, Placebo-controlled study in adult patients with diabetic nephropathy. Upon completion of screening, Enrolment and a 3-week Placebo-run-in period, patients were randomized to treatment with 1200 mg/day GC811007 or Placebo, administered as 2 identical 300-mg capsules taken orally twice daily (BID) before meals for 6 months.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A variable block randomisation schedule was used where a random number was assigned to each drug treatment pack and each pack sequentially assigned to blocks of varying sizes. Within each block, the drug treatment packs were sorted by random number and packs associated with the lower half of the random number set were assigned placebo, and those associated with the higher half were assigned active treatment. Assignment within blocks ensured that the number of active and placebo packs was equal once each block was full, to attain a balanced design in the event of early termination. The variable block size was a protection against unblinding.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/11/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 4155 0
New Zealand
State/province [1] 4155 0

Funding & Sponsors
Funding source category [1] 284750 0
Commercial sector/Industry
Name [1] 284750 0
Protemix Corporation Ltd
Country [1] 284750 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Protemix Corporation, Ltd.
Address
Level 28, IAG House
151 Queen Street,
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 283643 0
None
Name [1] 283643 0
Address [1] 283643 0
Country [1] 283643 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286871 0
Auckland Health & Disabilities Ethics Committee
Ethics committee address [1] 286871 0
650 Great South Road, Penrose, Auckland 1051, New Zealand
Ethics committee country [1] 286871 0
New Zealand
Date submitted for ethics approval [1] 286871 0
01/08/2000
Approval date [1] 286871 0
01/12/2000
Ethics approval number [1] 286871 0
99/147

Summary
Brief summary
This pilot study was designed to assess whether treatment with GC811007 would arrest the decline in renal function and the associated progression of diabetic retinopathy, peripheral neuropathy and autonomic neuropathy in patients with Type 2 diabetes mellitus. The safety and tolerability of GC811007 also were assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33811 0
Address 33811 0
Country 33811 0
Phone 33811 0
Fax 33811 0
Email 33811 0
Contact person for public queries
Name 17058 0
Dr Sally Poppitt
Address 17058 0
School of Biological Sciences
University of Auckland
Privvate Bag 92 019
Auckland 1142
Country 17058 0
New Zealand
Phone 17058 0
+64 (9) 630 5160
Fax 17058 0
Email 17058 0
[email protected]
Contact person for scientific queries
Name 7986 0
Dr Garth Cooper
Address 7986 0
School of Biological Sciences
University of Auckland
Privvate Bag 92 019
Auckland 1142
Country 7986 0
New Zealand
Phone 7986 0
+64 (9) 373 7599 Ext 87239
Fax 7986 0
Email 7986 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.