Diabetic NephropathyPhase 2NCT00320060
Effect of Pyridorin in Patients With Diabetic Nephropathy
A Phase 2 study testing Pyridorin (pyridoxamine dihydrochloride) in people with Diabetic Nephropathy, run by BioStratum.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of Pyridorin (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Pyridorin (pyridoxamine dihydrochloride)
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Jan 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes
- Sitting blood pressure of <=170/100 mm Hg at weeks -2 and -1
- Hemoglobin A1C <=12% at week -2
- Patients with diagnosis of diabetic nephropathy as defined by
- Serum Creatinine <=2.0 mg/dL at weeks -2 and -1
- Urinary albumin excretion >=300 mg/24 hours at week -2
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- Diagnosis of diabetic retinopathy
- Creatinine clearance >=40 mL/min at weeks -2 and -1
- Voluntary written consent to participate in this study
Who cannot join
- History of allergic or adverse response to any B vitamin
- History of major cardiovascular or cerebrovascular events
- History of cancer except adequately treated basal or squamous cell carcinoma of the skin
- History of diabetic ketoacidosis
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study to Evaluate the Safety and Tolerability of Pyridorin (Pyridoxamine Dihydrochloride) in Patients With Diabetic Nephropathy Associated With Type 1 or Type 2 Diabetes
The primary objective of the study is to evaluate the safety and tolerability of Pyridorin (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic kidney disease.
- Conditions
- Diabetic Nephropathy
- Being tested
- Pyridorin (pyridoxamine dihydrochloride)
- Keywords
- Diabetic nephropathy, Advanced Glycation Endproduct Inhibitor, Pyridorin, Pyridoxamine
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyridorin (pyridoxamine dihydrochloride)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startOct 2001
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 128 participants
Sponsor and investigators
- Lead sponsor
- BioStratum
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thorsten P Degenhardt, Ph.D., Study director, BioStratum, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320060
- Sponsor's protocol ID
- PYR-206
- Status last verified
- Apr 2006
- First submitted
- 27 Apr 2006
- Last updated
- 27 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study to Evaluate the Safety and Tolerability of Pyridorin (Pyridoxamine Dihydrochloride) in Patients With Diabetic Nephropathy Associated With Type 1 or Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00320060
- Acronym / sponsor ID
- PYR-206
- Conditions
- Diabetic Nephropathy
- Keywords
- Diabetic nephropathy, Advanced Glycation Endproduct Inhibitor, Pyridorin, Pyridoxamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants
- Lead sponsor
- BioStratumIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Study completion
- Jan 2003
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the safety and tolerability of Pyridorin (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes
- Sitting blood pressure of <=170/100 mm Hg at weeks -2 and -1
- Hemoglobin A1C <=12% at week -2
- Patients with diagnosis of diabetic nephropathy as defined by
- Creatinine clearance >=40 mL/min at weeks -2 and -1
Key exclusion criteria (4 listed)
- History of allergic or adverse response to any B vitamin
- History of major cardiovascular or cerebrovascular events
- History of cancer except adequately treated basal or squamous cell carcinoma of the skin
- History of diabetic ketoacidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyridorin (pyridoxamine dihydrochloride) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten P Degenhardt, Ph.D. study director
BioStratum, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyridorin (pyridoxamine dihydrochloride) in people with Diabetic Nephropathy, run by BioStratum.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2006.