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Minimal Change Disease (MCD)NEPTUNENCT01209000

Nephrotic Syndrome Study Network

An observational study of Minimal Change Disease (MCD) and Membranous Nephropathy, run by University of Michigan at 44 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual cost in the US of more than $3 billion. Read more about this study

Who is it for?
Ages Up to 80 years
What is being tested?
Kidney Biopsy
Type of treatment
Surgery or procedure
How many people
1,200 participants
Where
44 sitesin 2 countries
Study dates
Apr 2010to 31 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 Up to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with signs and symptoms of kidney disease consistent with FSGS, MCD, MN or proteinuric renal disease or pediatric participants not previously biopsied, who present for patient care at participating clinical centers will be eligible for Cohort A (biopsy cohort) study population targeted for enrollment into the NEPTUNE study. To establish a cohort of pediatric participants with incident nephrotic syndrome, Cohort B, a non-biopsy cohort has been initiated for Protocol V4.0. This population, <19 years of age, presenting for nephrotic syndrome and less than 30 days of immunosuppression therapy exposure, will also be targeted for enrollment into the cNEPTUNE study. Potential participants willing to receive their initial care and subsequent follow-up study visits at one of these sites are welcome to participate.

Who may be able to join

None listed.

Who cannot join

  • Prior solid organ transplant
  • A clinical diagnosis of glomerulopathy without diagnostic renal biopsy
  • Clinical, serological or histological evidence of systemic lupus erythematosus (SLE) as defined by the ARA criteria. Patients with membranous in combination with SLE will be excluded because this entity is well defined within the International Society of Nephrology/Renal Pathology Society categories of lupus nephritis, and frequently overlaps with other classification categories of SLE nephritis (68)
  • Clinical or histological evidence of other renal diseases (Alport, Nail Patella, Diabetic Nephropathy, IgA-nephritis, monoclonal gammopathy (multiple myelomas), genito-urinary malformations with vesico-urethral reflux or renal dysplasia)
  • Known systemic disease diagnosis at time of enrollment with a life expectancy less than 6 months
  • Unwillingness or inability to give a comprehensive informed consent
  • Unwillingness to comply with study procedures and visit schedule
  • Institutionalized individuals (e.g., prisoners)

Trial locations and contacts

44 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Chrysta C. Lienczewski, BS contact

734-615-5021

NEPTUNE-Study@umich.edu

Amanda Williams, BS contact

734-615-5017

NEPTUNE-Study@umich.edu

44 sites in 2 countries

United States39 sites, 34 recruiting

  • CS Mott Children's Hospital, University of Michigan

    Ann Arbor, Michigan, 48109

    Hailey Desmond, MS, 734-232-4851, heturner@umich.edu

    Debbie Gipson, MD, MS

    Recruiting

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

    Chrysta C. Lienczewski, BS - adult, 734-615-5021, boridley@med.umich.edu

    Amanda Williams, BS - adult, 734-615-5017, amwi@umich.edu

    Recruiting

  • Emory University and Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

    Emily Yun, 404-712-9998, emily.yun@emory.edu

    Laurence Greenbaum, MD, PhD

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Nathan Rogers, Nathan.Rogers@childrenscolorado.org

    Gabriel Cara-Fuentes, MD

    Not yet recruiting

  • University of Colorado Anschutz School of Medicine

    Aurora, Colorado, 80045

    Elizabeth Wagner, elizabeth.c.wagner@cuanschutz.edu

    Amber Podoll, MD

    Not yet recruiting

  • Johns Hopkins Medical Institute

    Baltimore, Maryland, 21287

    Sara Boynton, 443-287-9051, sboynto3@jhmi.edu

    Alicia Neu, MD

    Recruiting

  • Kidney Disease Section, NIDDK, NIH

    Bethesda, Maryland, 20892

    Completed

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Anne Froment, 919-923-1382, Anne_Froment@med.unc.edu

    Fernanda Ochoa, ferochoa@email.unc.edu

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    David Selewski, MD, MS

    Recruiting

  • Atrium Health Levine Children's Hospital

    Charlotte, North Carolina, 28203

    Layla Lo, nkauj.lo@atriumhealth.org

    Susan Massengill, MD

    Recruiting

  • John Stroger Cook County Hospital

    Chicago, Illinois, 60680

    Mathew Itteera, 312-864-4614, mitteera@cookcountyhhs.org

    Ambarish Athavale, MD

    Recruiting

  • University Hospital Rainbow Babies & Children's Hospital

    Cleveland, Ohio, 44106

    Completed

  • MetroHealth Hospital at Case Western Medical Center

    Cleveland, Ohio, 44109

    Completed

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Stefanie Larson, larsons2@ccf.org

    Villarreal

    Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Alexander Price, alexander.price2@osumc.edu

    Salem Almaani, MD

    Recruiting

  • University of Texas-Southwestern

    Dallas, Texas, 75390

    Elizabeth Robles, elizabeth.robles@utsouthwestern.edu

    Kamal Sambandam, MD

    Recruiting

  • Texas Children's Hospital - Baylor College of Medicine

    Houston, Texas, 77030

    Aisha Deslandes, aisha.deslandes@bcm.edu

    Shweta S. Shah, MD

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Catherine Creed, ccreed@kumc.edu

    Ellen McCarthy, MD

    Recruiting

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

    Kelsey Markus, kemarkus@cmh.edu

    Tarak Srivastava, MD

    Recruiting

  • University of Southern California-Children's Hospital

    Los Angeles, California, 90227

    Sharon Tang, BSN, 323-361-7299, shatang@chla.usc.edu

    Kevin Lemley, MD, PhD

    Recruiting

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

    Carlos Bidot, 305-243-8973, cbidot2@miami.edu

    Alessia Fornoni, MD. PhD

    Recruiting

  • Cohen Children's Hospital

    New Hyde Park, New York, 11040

    Suzanne Vento, BSN, 718-470-3499, svento@northwell.edu

    Christine Sethna, MD

    Recruiting

  • New York University Medical Center

    New York, New York, 10010

    Frank Modersitzki, MPH - adult, 212-686-7500 ext. 6379, Frank.Modersitzki@va.gov

    Laura Jane Pehrson - peds, laurajane.pehrson@nyulangone.org

    Recruiting

  • Bellevue Hospital

    New York, New York, 10016

    Frank Modersitzki, MPH, 212-686-7500 ext. 6379, Frank.Modersitzki@va.gov

    Laura Barisoni, MD

    Recruiting

  • New York University Veterans Administration

    New York, New York, 10016

    Frank Modersitzki, MPH, 212-686-7500 ext. 6379, Frank.Modersitzki@va.gov

    Laura Barisoni, MD

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Anup Pradhan, 212-305-6842, arp2209@cumc.columbia.edu

    Andrew Bomback, MD, MPH

    Recruiting

  • Stanford University School of Medicine

    Palo Alto, California, 94304

    Kshama Mehta, PhD, 650-736-1822, krmehta@stanford.edu

    Richard Lafayette, MD

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Alilya Edwards, EdwardsA1@chop.edu

    Kevin Meyers, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Krishna Kallem, MD - adult, MS, 484-358-0315, krishna.kallem@uphs.upenn.edu

    Aliya Edwards - peds, EdwardsA1@chop.edu

    Recruiting

  • Temple University

    Philadelphia, Pennsylvania, 19140

    Zoe Pfeffer, BS, 215-707-4712, zoe.pfeffer@tuhs.temple.edu

    Crystal Gadegbeku, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Completed

  • University of California San Francisco Benioff Children's Hospitals

    San Francisco, California, 94158

    Daniel Schrader, daniel.schrader@ucsf.edu

    Paul Brakeman, MD, PhD

    Not yet recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98145

    Emily Pao, emily.pao@seattlechildrens.org

    Sangeeta Hingorani, MD

    Recruiting

  • University of Washington

    Seattle, Washington, 98195

    Linda Manahan, BSN, lmanahan@nephrology.washington.edu

    Peter J. Nelson, MD

    Recruiting

  • Providence Medical Research Center

    Spokane, Washington, 99204

    Ann Cooper, CCRC, 509-474-4327, Ann.Cooper@providence.org

    Kelli Kuykendall, CCRC, 509-474-4320, Kelli.Kuykendall@providence.org

    Recruiting

  • Washington University - St Louis

    St Louis, Missouri, 63110

    Leslie Walther, leslie.walther@wustl.edu

    Vikas Dharnidharka, MD, PhD

    Not yet recruiting

  • Montefiore Medical Center

    The Bronx, New York, 11040

    Patti Flynn, RN, 718-655-1120, pflynn@montefiore.org

    Frederick Kaskel, MD

    Recruiting

  • Lundquist Biomedical Research Institute at Harbor UCLA Medical Center

    Torrance, California, 90502

    Janine LaPage, 310-222-4104, jlapage@labiomed.org

    Sharon Adler, MD

    Recruiting

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27157

    Withdrawn

Other trials in United States

Canada5 sites, 3 recruiting

  • York Central Hospital

    Richmond Hill, Ontario, L4C 4Z3

    Completed

  • Scarborough Hospital

    Scarborough Village, Ontario, M1H 3G4

    Completed

  • Credit Valley Hospital

    Toronto, Ontario, L5M 2N1

    Martin Romano, MD, 416-340-3514, martin.romano@thp.ca

    Phillip Boll, MD

    Recruiting

  • Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

    Rhea O'Neill, rhea.oneill@sri.utoronto.ca

    Michelle Hladunewich, MD

    Recruiting

  • University Health Network

    Toronto, Ontario, M5G2C4

    Paul Ling, MD, 416-340-3514, pling@uhnresearch.ca

    Martin Romano, MD, Martin.Romano@trilliumhealthpartners.ca

    Recruiting

Other trials in Canada

About this study

Official title: Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network

Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual cost in the US of more than $3 billion. However, the clinical classification of these diseases is widely believed to be inadequate by the scientific community. Given the poor understanding of MCD/FSGS and MN biology, it is not surprising that the available therapies are imperfect. The therapies lack a clear biological basis, and as many families have experienced, they are often not beneficial, and in fact may be significantly toxic. Given these observations, it is essential that research be conducted that address these serious obstacles to effectively caring for patients.

In response to a request for applications by the National Institutes of Health, Office of Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a number of affiliated universities joined together with The NephCure Foundation the NIDDK, the ORDR, and the University of Michigan in collaboration towards the establishment of a Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium.

Through this consortium the investigators hope to understand the fundamental biology of these rare diseases and aim to bank long-term observational data and corresponding biological specimens for researchers to access and further enrich.

Read the detailed description

Idiopathic Nephrotic Syndrome (NS) is a rare disease syndrome responsible for approximately 12% of all causes of end-stage kidney disease (ESRD) and up to 20% of ESRD in children. Treatment strategies for Focal and Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD) and Membranous Nephropathy (MN), the major causes of NS, include high dose prolonged steroid therapy, cyclophosphamide, cyclosporine A, tacrolimus, mycophenolate mofetil and other immunosuppressive agents, which all carry significant side effects. Failure to obtain remission using the current treatment approaches frequently results in progression to ESRD with its associated costs, morbidities, and mortality. In the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) registry, half of the pediatric patients with Steroid Resistant Nephrotic Syndrome required renal replacement therapy within two years of being enrolled in the disease registry. FSGS also has a high recurrence rate following kidney transplantation (30-40%) and is the most common recurrent disease leading to allograft loss.

The prevailing classification of Nephrotic Syndrome categorizes patients into FSGS, MCD, and MN, if in the absence of other underlying causes, glomerular histology shows a specific histological pattern. This classification does not adequately predict the heterogeneous natural history of patients with FSGS, MCD, and MN. Major advances in understanding the pathogenesis of FSGS and MCD have come over the last ten years from the identification of several mutated genes responsible for causing Steroid Resistant Nephrotic Syndrome (SRNS) presenting with FSGS or MCD histopathology in humans and model organisms. These functionally distinct genetic disorders can present with indistinguishable FSGS lesions on histology confirming the presence of heterogeneous pathogenic mechanisms under the current histological diagnoses.

The limited understanding of FSGS, MCD, and MN biology in humans has necessitated a descriptive classification system in which heterogeneous disorders are grouped together. This invariably consigns these heterogeneous patients to the same therapeutic approaches, which use blunt immunosuppressive drugs that lack a clear biological basis, are often not beneficial, and are complicated by significant toxicity. The foregoing shortcomings make a strong case that concerted and innovative investigational strategies combining basic science, translational, and clinical methods should be employed to study FSGS, MCD, and MN. It is for these reasons that the Nephrotic Syndrome Study Network is established to conduct clinical and translational research in patients with FSGS/MCD and MN.

Being tested
Kidney Biopsy
Keywords
Focal and Segmental Glomerulosclerosis, Focal & Segmental Glomerulosclerosis, Focal Segmental Glomerulosclerosis, FSGS, Minimal change disease, MCD, Membranous Nephropathy, MN, Nephrotic Syndrome, Neph Syndrome, NEPTUNE, NephCure, Halpin
Medical subject headings
Nephrosis, Lipoid, Glomerulonephritis, Membranous, Glomerulosclerosis, Focal Segmental, Macular dystrophy, corneal type 1, Nephrotic Syndrome

What participants receive

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

  • Kidney BiopsyProcedure or surgery

    Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core, to be set aside until all clinical care is complete.

Study groups in NCT01209000
Study groupRoleWhat they receive
FSGS/MCD Cohort (Cohort A)Focal Segmental Glomerulosclerosis/Minimal Change Disease (FSGS/MCD) Cohort Participants enrolled in NEPTUNE with a biopsy proven histological diagnosis for FSGS or MCD. Eligible participants must be scheduled for a clinically indicated renal biopsy.
Receives: Procedure: Kidney Biopsy
MN Cohort (Cohort A)Membranous Nephropathy (MN) Cohort Participants enrolled in NEPTUNE with a biopsy proven histological diagnosis for MN. Eligible participants must be scheduled for a clinically indicated renal biopsy.
Receives: Procedure: Kidney Biopsy
Other glomerulopathies cohortParticipants enrolled in NEPTUNE and determined to not have FSGS/MCD or MN will be followed in a third group. Eligible participants must be scheduled for a clinically indicated renal biopsy.
Receives: Procedure: Kidney Biopsy
cNEPTUNE (Cohort B)Participants < 19 years of age, with < 30 days exposure to immunosuppression therapy who are not scheduled for renal biopsy.

What is being measured

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

  1. Event rate of change in urinary protein excretion and renal function.

    Defined as remission, partial remission and non-remission

    Measured: 60 months

  2. Rate of change in renal function.

    Defined as:

    1. 25 mls/min/1.73m2 reduction in follow-up estimated GFR (using the 4-variable MDRD equation for ages ≥18 years and modified Schwartz for ages <18 years) compared to baseline estimated GFR
    2. 50% decline in follow-up estimated GFR compared to baseline measurement
    3. End stage renal disease defined as estimated GFR ≤10cc/min, initiation of maintenance dialysis or preemptive kidney transplantation.

    Measured: 60 months

Secondary outcomes (9)

  1. Quality of Life:

    Patient-reported outcome will be assessed using Quality of Life questionnaires at regular intervals as stipulated in the visit calendar using the SF-36, PedsQL and the Patient Reported Outcome Measurement Information System (PROMIS) (in the age-appropriate groups).

    Measured: 60 months

  2. Malignancies

    Any cancer diagnosis of the skin, hematopoietic system, or solid organ after enrollment in NEPTUNE

    Measured: 60 months

  3. Infections, Serious and Systemic

    Infections including one of the following:

    1. Documented diagnosis of infection of the skin or subcutaneous tissue (e.g. cellulitis), vascular system, peritoneum, or any vital organ requiring the use of parenteral antibiotics and/or oral antibiotics alone or in combination for a treatment interval of ≥72 hours.
    2. Hospitalization for treatment of infection

    Measured: 60 months

  4. Thromboembolic Events

    Documented diagnosis of one of the following:

    1. Embolic cerebrovascular accident
    2. Deep venous thrombosis
    3. Renal vein thrombosis or
    4. Pulmonary embolus

    Measured: 60 months

  5. Hospitalization

    Documented hospital admission, including observation for ≥24 hours.

    Measured: 60 months

  6. Emergency Department/ Observation Unit Visit

    Documented visit to an emergency department or observation unit that does not lead to hospitalization and is less than 24 hours.

    Measured: 60 months

  7. Acute Kidney Injury

    Documented diagnosis of acute kidney injury as defined by the AKIN (Mehta et al., Critical Care 2007, 11:R31) and/or renal failure requiring renal replacement therapy <3 months.

    Measured: 60 months

  8. Death

    1. Documentation of death that is secondary to infection or sepsis.
    2. Cardiovascular/Cerebrovascular-related Death: Sudden death; Myocardial infarction; Congestive heart failure; Primary intractable serious arrhythmia; Peripheral vascular disease; Ischemic cerebrovascular accident; Hemorrhagic cerebrovascular accident; Thromboembolic event
    3. Documentation of death secondary to cancer
    4. Other Death: Documentation of death that does not fall into the above categories.

    Measured: 60 months

  9. New Onset Diabetes

    Diagnosis of diabetes as indicated by 1 or more of the following not present at NEPTUNE Enrollment:

    1. Documented diagnosis of diabetes in medical record
    2. Casual (non-fasting) blood glucose > 200 mg/dL c) Fasting blood glucose > 126 mg/dL d) 2 hour glucose > 200 after oral glucose tolerance test e) chronic use (>6 mos) hypoglycemic therapy outside of pregnancy f) Hemogloblin A1C >= 6.5%

    Measured: 60 months

Timeline

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

  1. First posted24 Sep 2010 (estimated)
  2. Study startApr 2010
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01209000
Sponsor's protocol ID
6801
Other IDs
1U54DK083912, 1R01DK141114-01A1
Acronym
NEPTUNE
Status last verified
Jun 2026
First submitted
29 Jul 2010
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang CS, Troost JP, Wang Y, Greenbaum LA, Gibson K, Trachtman H, Srivastava T, Reidy K, Kaskel F, Sethna CB, Meyers K, Dell KM, Tran CL, Hingorani S, Lemley KV, Lin JJ, Gipson DS. Determinants of medication adherence in childhood nephrotic syndrome and associations of adherence with clinical outcomes. Pediatr Nephrol. 2022 Jul;37(7):1585-1595. doi: 10.1007/s00467-021-05176-8. Epub 2021 Nov 18.

    PubMed 34796395

  • Solagna F, Tezze C, Lindenmeyer MT, Lu S, Wu G, Liu S, Zhao Y, Mitchell R, Meyer C, Omairi S, Kilic T, Paolini A, Ritvos O, Pasternack A, Matsakas A, Kylies D, Wiesch JSZ, Turner JE, Wanner N, Nair V, Eichinger F, Menon R, Martin IV, Klinkhammer BM, Hoxha E, Cohen CD, Tharaux PL, Boor P, Ostendorf T, Kretzler M, Sandri M, Kretz O, Puelles VG, Patel K, Huber TB. Pro-cachectic factors link experimental and human chronic kidney disease to skeletal muscle wasting programs. J Clin Invest. 2021 Jun 1;131(11):e135821. doi: 10.1172/JCI135821.

    PubMed 34060483

  • Kang H, Kim DR, Jung YH, Baek CW, Park YH, In Oh J, Kim WJ, Choi GJ. Pre-warming the Streamlined Liner of the Pharynx Airway (SLIPA) improves fitting to the laryngeal structure: a randomized, double-blind study. BMC Anesthesiol. 2015 Nov 20;15:167. doi: 10.1186/s12871-015-0151-4.

    PubMed 26589142

  • Hogan MC, Lieske JC, Lienczewski CC, Nesbitt LL, Wickman LT, Heyer CM, Harris PC, Ward CJ, Sundsbak JL, Manganelli L, Ju W, Kopp JB, Nelson PJ, Adler SG, Reich HN, Holzmann LB, Kretzler M, Bitzer M. Strategy and rationale for urine collection protocols employed in the NEPTUNE study. BMC Nephrol. 2015 Nov 17;16:190. doi: 10.1186/s12882-015-0185-3.

    PubMed 26577187

Questions about this trial

What is this clinical trial studying?

An observational study of Minimal Change Disease (MCD) and Membranous Nephropathy, run by University of Michigan at 44 sites in 2 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 0 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chrysta C. Lienczewski, BS (734-615-5021, NEPTUNE-Study@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event rate of change in urinary protein excretion and renal function. (time frame: 60 months). The study lists 2 primary outcomes in all. 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 NCT01209000, which also lists 4 linked publications.

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 10 Jun 2026.

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