Pyridorin in Diabetic Nephropathy (PIONEER)
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|ClinicalTrials.gov Identifier: NCT02156843|
Recruitment Status : Terminated
First Posted : June 5, 2014
Last Update Posted : March 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Nephropathy Diabetic Kidney Disease||Drug: Pyridorin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||328 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Pyridorin (Pyridoxamine Dihydrochloride) in Subjects With Nephropathy Due to Type 2 Diabetes (PIONEER)|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||March 2018|
Pyridorin (pyridoxamine dihydrochloride) 300 mg oral BID (twice daily, every 12 hours) Capsule
300 mg BID (twice daily, every 12 hours), oral capsule taken until end stage renal disease or death occurs, or the study is terminated by the sponsor.
Other Name: pyridoxamine dihydrochloride
Placebo Comparator: Placebo
Placebo Oral Capsule taken BID (twice daily, every 12 hours)
Placebo excipients without the active drug, oral capsule taken BID (twice daily, every 12 hours), until end stage renal disease or death occurs, or the study is terminated by the sponsor.
- Time to composite endpoint of >=50% SCr increase from baseline or ESRD [ Time Frame: Approximately 45 Months ]Time to the composite endpoint consisting of the earliest event amongst a SCr increase of 50% from baseline that occurs during follow-up; or End Stage Renal Disease. ESRD is defined as the initiation of permanent dialysis, receiving a kidney transplant, or a SCr value >= 6.0 mg/dL (530 umol/L) with a second SCr confirmation value >=6.0 mg/dL (530 umol/L) obtained 4-6 weeks later. A confirmation of SCr value for subjects with ESRD and initiation of permanent dialysis or kidney transplant will not be collected.
- Time to the composite endpoint >=100% SCr increase or ESRD [ Time Frame: Approximately 45 Months ]A SCr increase of >=100% that occurs during follow-up; or ESRD
- Change in serum cystatin-C [ Time Frame: Change from baseline to Week 52 and from baseline to Week 104 ]
- Change in urine protein/creatinine ratio (PCR) [ Time Frame: From baseline to Week 52 and from baseline to Week 104 ]
- Change in urinary transforming growth factor-beta (TGF-Beta) excretion [ Time Frame: From baseline to Week 52 and from baseline to Week 104 ]
- Change in SCr [ Time Frame: From baseline to Week 52 and from baseline to Week 104 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156843
|Study Chair:||Jamie Dwyer, MD||The Collaborative Study Group (CSG) [Co-Chair]|
|Study Chair:||Julia B. Lewis, MD||The Collaborative Study Group (CSG)|