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Diabetic NephropathyPhase 3PIONEERNCT02156843

Pyridorin in Diabetic Nephropathy

A Phase 3 study testing Pyridorin in people with Diabetic Nephropathy and Diabetic Kidney Disease, run by NephroGenex, Inc. at 137 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Nephropathy, Diabetic Kidney Disease
What is being tested?
Pyridorin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
328 participants
Where
137 sitesin 12 countries
Study dates
Jun 2014to Mar 2018
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients meeting all of the following criteria will be eligible to participate in the study:
  • Patients who have given voluntary written informed consent to participate in this study prior to conducting Screening (Visit 1) procedures;
  • Patients 18 years of age or older with a diagnosis of type 2 diabetes;
  • 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 (women of childbearing potential is defined as all women who are not surgically sterile or are not at least 1 year post menopausal). All women of childbearing potential must have a negative serum pregnancy test at Visit 1;
  • All men (unless surgically sterile, as defined below) who have sexual intercourse with a WOCBP must agree and commit to use a highly effective method of contraception for the duration of the study (defined as the time of the signing of the informed consent form through the conclusion of patient participation). Highly effective methods of contraception include:
  • Male subjects agreeing that they and their female spouse/partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential.
Show all 17Show fewer
  • To be considered surgically sterilized, a male partner must have had a vasectomy at least 24 weeks before Visit 1;
  • At Visit 1, patients must have a history of overt diabetic nephropathy, as defined by the following:
  • A SCr measurement ≥1.3 (≥1.25)mg/dL (111 µmol/L) for females or ≥1.5 (≥1.45) mg/dL (128 µmol/L) for males;
  • At Visit 1 or 1.1 24-hour urine collection PCR >1200 mg/g (130 mg/µmol) and, if applicable for PS phase, at Visit 1S or 1.1S a 24-urine collection PCR >600 mg/g (67 mg/µmol)
  • For eligibility determination, laboratory reported values of PCR will be rounded up to 2 significant digits (e.g. ≥1150 mg/g to 1200 mg/g; ≥595 mg/g to 600 mg/g),
  • Patients must have a SCr measurement <3.0 mg/dL (265 µmol/L);
  • Patients must have an eGFR of ≥20 mL/min/1.73m2, using the 4-variable Modification of Diet in Renal Disease equation in which eGFR = 175 x (SCr(mg/dL))-1.154 x (Age(years))-0.203 x (0.742 if female) x (1.212 if African American);
  • Patient must have a second screening SCr measurement at Visit 1.1 or 1.1S taken 1 week (± 2 days) after screening (Visit 1 or 1S). The value of the second screening SCr measurement must be <3.0 mg/dL (265 µmol/L) for both genders and within 25% of the first screening measurement;
  • Patients must be taking a single ACE-I or ARB at a constant dose for at least 26 weeks prior to Visit 1, where the dose of the ACE-I or the ARB is considered appropriate for that patient (can be zero to max dose approved by the FDA) and it is anticipated that the same dose can and will be maintained throughout the course of the study;
  • Patients taking any blood pressure medications in addition to an ACE-I or ARB, including diuretics, must be on a stable dose for 13 weeks prior to Visit 1 (and Visit 1S if applicable) with a seated blood pressure of ≤ 150/90 mmHg;
  • Patients not taking any blood pressure medications, including diuretics, other than an ACE-I or ARB must have a seated blood pressure ≤ 150/90 mmHg at Visit 1 (and Visit 1S if applicable) and a seated blood pressure considered appropriate for the patient and one that can be sustained throughout the study.

Who cannot join

  • Patients are excluded from participation in the study if any of the following criteria apply
  • Patients with type 1 diabetes or MODY (a monogenic form of diabetes);
  • Patients with a diagnosis of chronic kidney 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 26 weeks of Visit 1
  • Patients with a history of solid organ transplantation
  • Patients with a history of myocardial infarction, coronary re-vascularization procedures (including percutaneous transluminal coronary angioplasty), stroke, or transient ischemic attack within 30 days prior to Visit 1
Show all 23Show fewer
  • Patients with a diagnosis of New York Heart Association Class III or IV congestive heart failure at any time
  • Patients with a history of being treated for neoplastic disease (except basal or squamous cell carcinoma of the skin) within 5 years prior to Visit 1
  • Patients with any history of dialysis within 2 years prior to Visit 1
  • Patients in whom dialysis or renal transplantation is anticipated by their physician within 1 year after Visit 1
  • Patients who used SCr-altering drugs within 30 days prior to Visit 1
  • 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 × the upper limit of normal (ULN) measured at Visit 1.1 or Visit 1.1S
  • Patients with bilirubin levels >1.5 × ULN measured at Visit 1.1 or Visit 1.1S
  • 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 an active history of dysphagia or swallowing disorders
  • Patients with a history of hypersensitivity to Pyridorin or any of the excipients (non-active ingredients) in the Pyridorin formulation
  • Patients who have taken pyridoxamine or any other investigational drug within 30 days prior to Visit 1, or have participated in a previous Pyridorin study or another interventional clinical study within 30 days prior to Visit 1
  • Patients with an active history of drug or alcohol abuse
  • Patients unlikely to comply with the study protocol (eg, 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
  • Persons employed with the sponsor, CRO, or one of the study investigative sites must be excluded from participation, even if they are not involved directly in the conduct of the study.

Trial locations and contacts

137 sites in 12 countries.

137 sites in 12 countries

United States55 sites

  • CSG Investigational Site (#153)

    Arvada, Colorado, 80002

  • CSG Investigational Site (#108)

    Asheville, North Carolina, 28801

  • CSG Investigational Site (#118)

    Aurora, Colorado, 80045

  • CSG Investigational Site (#157)

    Birmingham, Alabama, 35294

  • CSG Investigational Site (#117)

    Boston, Massachusetts, 02111

  • CSG Investigational Site (#128)

    Buffalo, New York, 14215

  • CSG Investigational Site (#107)

    Burlington, Vermont, 05401

  • CSG Investigational Site (#116)

    Charlotte, North Carolina, 28207

  • CSG Investigational Site (#129)

    Charlottesville, Virginia, 22908

  • CSG Investigational Site (#131)

    Chattanooga, Tennessee, 37408

  • CSG Investigational Site (#113)

    Chicago, Illinois, 60607

  • CSG Investigational Site (#124)

    Cincinnati, Ohio, 45267

  • CSG Investigational Site (#151)

    Cleveland, Ohio, 44106

  • CSG Investigational Site (#123)

    Cleveland, Ohio, 44195

  • CSG Investigational Site (#156)

    Columbus, Georgia, 31901

  • CSG Investigational Site (#106)

    Columbus, Ohio, 43210

  • CSG Investigational Site (#119)

    Dallas, Texas, 75390

  • CSG Investigational Site (#111)

    Detroit, Michigan, 48202

  • CSG Investigational Site (#125)

    Durham, North Carolina, 27710

  • CSG Investigational Site (#137)

    Fairfax, Virginia, 22030

  • CSG Investigational Site (#103)

    Fairfax, Virginia, 22033

  • CSG Investigational Site (#147)

    Greenbelt, Maryland, 20770

  • CSG Investigational Site (#104)

    Hampton, Virginia, 23666

  • CSG Investigational Site (#139)

    Houston, Texas, 77004

  • CSG Investigational Site (#133)

    Houston, Texas, 77076

  • CSG Investigational Site (#162)

    Kansas City, Missouri, 64111

  • CSG Investigational Site (#152)

    Kansas City, Missouri, 64128

  • CSG Investigational Site (#141)

    Las Vegas, Nevada, 89115

  • CSG Investigational Site (#160)

    Los Angeles, California, 90048

  • CSG Investigational Site (#102)

    Michigan City, Indiana, 46360

  • CSG Investigational Site (#109)

    Midland, Texas, 79707

  • CSG Investigational Site (#122)

    Milwaukee, Wisconsin, 53295

  • CSG Investigational Site (#105)

    Nashville, Tennessee, 37205

  • CSG Investigational Site (#155)

    New Bern, North Carolina, 28562

  • CSG Investigational Site (#115)

    New Orleans, Louisiana, 70112

  • CSG Investigational Site (#136)

    Northport, New York, 11768

  • CSG Investigational Site (#148)

    Parma Heights, Ohio, 44130

  • CSG Investigational Site (#101)

    Philadelphia, Pennsylvania, 19104

  • CSG Investigational Site (#130)

    Phoenix, Arizona, 85012

  • CSG Investigational Site (#150)

    Phoenix, Arizona, 85054

  • CSG Investigational Site (#149)

    Pittsburgh, Pennsylvania, 15240

  • CSG Investigational Site (#134)

    Pontiac, Michigan, 48341

  • CSG Investigational Site (#145)

    Prescott, Arizona, 86301

  • CSG Investigational Site (#146)

    Providence, Rhode Island, 02903

  • CSG Investigational Site (#144)

    Richmond, Virginia, 23249

  • CSG Investigational Site (#143)

    Riverside, California, 92505

  • CSG Investigational Site (#159)

    Roseville, California, 95661

  • CSG Investigational Site (#132)

    Salt Lake City, Utah, 84112

  • CSG Investigational Site (#121)

    Spokane, Washington, 99204

  • CSG Investigational Site (#114)

    Springfield, Massachusetts, 01107

  • CSG Investigational Site (#142)

    Tucson, Arizona, 85745

  • CSG Investigational Site (#158)

    Waterbury, Connecticut, 06708

  • CSG Investigational Site (#154)

    West Nyack, New York, 10994

  • CSG Investigational Site (#120)

    Westminster, Colorado, 80031

  • CSG Investigational Site (#127)

    Winston-Salem, North Carolina, 27157

Other trials in United States

Israel16 sites

  • CSG Investigational Site (#307)

    Ashkelon, 78278

  • CSG Investigational Site (#313)

    Beersheba, 84101

  • CSG Investigational Site (#300)

    Haifa, 31096

  • CSG Investigational Site (#304)

    Holon, 58100

  • CSG Investigational Site (#306)

    Jerusalem, 91120

  • CSG Investigational Site (#314)

    Jerusalem, 93106

  • CSG Investigational Site (#309)

    Kfar Saba, 44281

  • CSG Investigational Site (#302)

    Nahariya, 22100

  • CSG Investigational Site (#312)

    Petah Tikva, 49100

  • CSG Investigational Site (#315)

    Poria – Neve Oved, 15208

  • CSG Investigational Site (#311)

    Rishon LeZiyyon, 75650

  • CSG Investigational Site (#308)

    Safed, Zefad, 13100

  • CSG Investigational Site (#305)

    Tel Aviv, 62039

  • CSG Investigational Site (#303)

    Tel Aviv

  • CSG Investigational Site (#310)

    Tel Hasomer, 52621

  • CSG Investigational Site (#301)

    Ẕerifin, 70300

Other trials in Israel

Hungary13 sites

  • CSG Investigational Site (#501)

    Balatonfüred, 8230

  • CSG Investigational Site (#509)

    Budapest, 1032

  • CSG Investigational Site (#513)

    Budapest, 1036

  • CSG Investigational Site (#505)

    Budapest, 1096

  • CSG Investigational Site (#507)

    Debrecen, 4032

  • CSG Investigational Site (#508)

    Gyula, 5701

  • CSG Investigational Site (#502)

    Hatvan, 3000

  • CSG Investigational Site (#504)

    Kaposvár, 7400

  • CSG Investigational Site (#510)

    Kisvárda, 4600

  • CSG Investigational Site (#506)

    Pécs, 7623

  • CSG Investigational Site (#514)

    Székesfehérvár, 8000

  • CSG Investigational Site (#500)

    Szikszó, 3800

  • CSG Investigational Site (#503)

    Zalaegerszeg, 8900

Other trials in Hungary

Australia9 sites

  • CSG Investigative Site (#204)

    Adelaide, South Australia, 5000

  • CSG Investigational Site (#205)

    Camperdown, New South Wales, 2050

  • CSG Investigational Site (#207)

    Footscray, Victoria, 2011

  • CSG Investigational Site (#201)

    Gosford, New South Wales, 2250

  • CSG Investigational Site (#206)

    Liverpool, New South Wales, 2170

  • CSG Investigational Site (#209)

    Parkville, 3050

  • CSG Investigational Site (#200)

    Reservoir, Victoria, 3073

  • CSG Investigational Site (#202)

    Richmond, Victoria, 3121

  • CSG Investigational Site (#208)

    St Leonards, New South Wales, 2065

Other trials in Australia

Bulgaria8 sites

  • CSG Investigational Site (#757)

    Plovdiv

  • CSG Investigational Site (# 750)

    Sofia

  • CSG Investigational Site (# 755)

    Sofia

  • CSG Investigational Site (# 756)

    Sofia

  • CSG Investigational Site (#751)

    Sofia

  • CSG Investigational Site (#752)

    Sofia

  • CSG Investigational Site (#753)

    Sofia

  • CSG Investigational Site (#754)

    Stara Zagora

Other trials in Bulgaria

Germany8 sites

  • CSG Investigational Site (#709)

    Aschaffenburg, 63739

  • CSG Investigative Site (#702)

    Berlin, 10249

  • CSG Investigational Site (#706)

    Elsterwerda, 04910

  • CSG Investigational Site (#703)

    Heidelberg, 69115

  • CSG Investigational Site (#707)

    Herzberg, 04916

  • CSG Investigational Site (#701)

    Hoyerswerda, 02977

  • CSG Investigational Site (#708)

    Mainz, 55116

  • CSG Investigational Site (#700)

    München, 81675

Other trials in Germany

Spain8 sites

  • CSG Investigational Site (#605)

    Barcelona, 08003

  • CSG Investigational Site (#606)

    Barcelona, 08022

  • CSG Investigational Site (#603)

    Barcelona, 08025

  • CSG Investigational Site (#604)

    Barcelona, 08907

  • CSG Investigational Site (#600)

    Girona, 17007

  • CSG Investigational Site (# 607)

    Lleida, 25198

  • CSG Investigational Site (#601)

    San Sebastián de los Reyes, Madrid, 28702

  • CSG Investigational Site (#602)

    Valencia, 46017

Other trials in Spain

France7 sites

  • CSG Investigational Site (#800)

    Boulogne-sur-Mer, 62321

  • CSG Investigational Site (#803)

    Colmar, 68024

  • CSG Investigational Site (#801)

    Grenoble, Cedex, 38043

  • CSG Investigational Site (#806)

    Montpellier, 34295

  • CSG Investigational Site (#802)

    Paris, Cedex, 75877

  • CSG Investigational Site (#804)

    Rhone, 69310

  • CSG Investigational Site (#805)

    Valenciennes, 59322

Other trials in France

Poland6 sites

  • CSG Investigational Site (#651)

    Bydgoszcz

  • CSG Investigational Site (#655)

    Chojnice

  • CSG Investigational Site (#653)

    Kielce

  • CSG Investigational Site (#657)

    Nowy Sącz

  • CSG Investigational Site (#652)

    Poznan

  • CSG Investigational Site (#656)

    Poznan

Other trials in Poland

Hong Kong3 sites

  • CSG Investigational Site (#400)

    Hong Kong

  • CSG Investigational Site (#402)

    Kwai Chung

  • CSG Investigational Site (#401)

    Shatin

Other trials in Hong Kong

Puerto Rico3 sites

  • CSG Investigational Site (#112)

    Rio Piedras, 00935

  • CSG Investigational Site (#110)

    San Juan, 00918

  • CSG Investigational Site (#135)

    Toa Baja, 00949

Other trials in Puerto Rico

Mauritius1 site

  • CSG Investigational Site (# 850)

    Phoenix

Other trials in Mauritius

About this study

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)

The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, multi-center Phase 3 study to evaluate the safety and efficacy of Pyridorin 300 mg BID (twice daily, every 12 hours) in subjects with nephropathy due to type 2 diabetes mellitus. In this study, nephropathy is defined as a Serum Creatinine (SCr) >= 1.3 (≥1.25) mg/dL (111 umol/L) for female and >=1.5 (≥1.45) mg/dL (128 umol/L) for male subjects and a 24-hour urine collection protein/creatinine ration (PCR) >=1200 mg/g (136 mg/mmol), and if applicable for PS Phase, at Visit 1S or 1.1S a 24-urine collection PCR ≥600 mg/g (68 mg/mmol). Subjects must have a baseline SCr < 3.0 mg/dL (265 umol/L) and must be on previously established standard of care at screening.

Being tested
Pyridorin, Placebo
Keywords
Diabetic Kidney Disease, Nephropathy, Diabetic Nephropathy, Kidney Disease, Type 2 Diabetes
Medical subject headings
Diabetic Nephropathies, Kidney Diseases, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PyridorinDrug

    Also called pyridoxamine dihydrochloride

    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.

  • PlaceboDrug

    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.

Study groups in NCT02156843
Study groupRoleWhat they receive
PyridorinExperimentalPyridorin (pyridoxamine dihydrochloride) 300 mg oral BID (twice daily, every 12 hours) Capsule
Receives: Drug: Pyridorin
PlaceboPlacebo comparatorPlacebo Oral Capsule taken BID (twice daily, every 12 hours)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to composite endpoint of >=50% SCr increase from baseline or ESRD

    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.

    Measured: Approximately 45 Months

Secondary outcomes (1)

  1. Time to the composite endpoint >=100% SCr increase or ESRD

    A SCr increase of >=100% that occurs during follow-up; or ESRD

    Measured: Approximately 45 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionDec 2017 (estimated)
  4. Study completionMar 2018 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
328 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02156843
Sponsor's protocol ID
PYR-311
Other IDs
2014-001641-24, CSG-17, PYR-311 (PIONEER), 2014
Acronym
PIONEER
Status last verified
Mar 2016
First submitted
28 May 2014
Last updated
9 Mar 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pyridorin in people with Diabetic Nephropathy and Diabetic Kidney Disease, run by NephroGenex, Inc. at 137 sites in 12 countries.

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 17 inclusion and 23 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: stopped early, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States, Israel, Hungary, Australia, Bulgaria and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early. Results are not available in the source record.

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.

What does the primary outcome measure?

Time to composite endpoint of >=50% SCr increase from baseline or ESRD (time frame: Approximately 45 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02156843.

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 9 Mar 2016; AzTrials last refreshed its copy on 1 Nov 2026.

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