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Acute Kidney FailureKPMPNCT04334707

Kidney Precision Medicine Project

An observational study of Acute Kidney Failure and Acute Kidney Insufficiency, run by Icahn School of Medicine at Mount Sinai at 13 sites in United States.

Recruiting

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

Sites and contacts
Official record
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Trial summary

Acute kidney injury (AKI) and chronic kidney disease (CKD) impose a significant global health burden. Yet, no effective therapies currently exist for AKI, and only a few are available for CKD. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Kidney Biopsy, MRI and Retina Scan
How many people
1,000 participants
Where
13 sitesUnited States
Study dates
1 Sep 2019to 30 Jun 2027
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The KPMP will focus on participant populations that account for large proportions of the public health burden of acute and chronic kidney diseases as evidenced by research and federal data. For CKD, high priority populations include CKD in the setting of diabetes (diabetic kidney disease, DKD) and hypertension-associated CKD (H-CKD). A special population of people with long-standing type 1 diabetes (more than 25 years) who remain free of clinically-evident DKD will also be included. For AKI, the focus will be on acute intrinsic non-glomerular disease, primarily on acute tubular necrosis (ATN). KPMP will also include a special population of patients at risk for AKI or with early AKI captured by an open (surgical) kidney biopsy performed at the time of clinically indicated laparotomy. The rationale for including this special AKI population is that AKI often occurs early in the clinical course of conditions like sepsis, major surgery and trauma.

Chronic Kidney Disease Subjects Inclusion Criteria Diabetic kidney disease (DKD)

  • Diagnosis of diabetes mellitus (type 1 or 2) established by at least one of the following criteria:
  • Hemoglobin A1C greater than or equal to 6.5%, confirmed with a repeat test within the past year
  • Fasting blood sugar greater than or equal to 126 mg/dL, confirmed with a repeat test within the past year
  • Use of glucose-lowering therapy (insulin or oral or other subcutaneous agents)
  • International Classification of Diseases (ICD) 9/10 diagnostic code for diabetes
  • Evidence of persistent kidney damage, manifest as any of the following present on at least two clinic assessments prior to enrollment and at least 3 months apart and excluding people with acute medical illnesses and changing kidney function:
  • Estimated glomerular filtration rate 30-59 mL/min/1.73m2 or
  • Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine albumin excretion greater than or equal to 30 mg/g creatinine (or mg/day) or
  • Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine protein excretion greater than or equal to 150 mg/g creatinine (or mg/day)
  • Most recent eGFR must be within the past year and be ≥30 mL/min/1.73m^2.

Hypertension-associated Chronic Kidney Disease (H-CKD)

  • Diagnosis of hypertension (HTN) established by at least one of the following criteria:
  • BP greater than 140/90 mmHg measured on three occasions over at least 1 month
  • Taking antihypertensive medication for blood pressure (BP) control
  • International Classification of Diseases (ICD) 9/10 diagnostic code for hypertension
  • Evidence of persistent kidney damage, manifested as any of the following present on at least two assessments at least 3 months apart and excluding people with acute medical illnesses and changing kidney function: Estimated glomerular filtration rate 30-59 mL/min/1.73m2 on two assessments at least 3 months apart with albuminuria less than or equal to 2000 mg/g creatinine (or mg/day), or proteinuria less than or equal to 3000 mg/g creatinine (or mg/day), or ≤1+ proteinuria on urinalysis, or
  • Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine albumin excretion 30-2000 mg/g creatinine (or mg/day) or
  • Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine protein excretion 150-3000 mg/g creatinine (or mg/day)
  • Most recent eGFR must be within the past year and be ≥30 mL/min/1.73m2

Acute Kidney Injury Inclusion Criteria Baseline estimated glomerular filtration rate greater than 45 mL/min/1.73m2. Baseline defined by the median of the last three outpatient serum creatinine measurements from day 7 to 365 prior to enrollment.

  • If only two measurements are obtained within this window, the two results will be averaged.
  • If only one measurement was obtained within this window, this result will be used
  • If baseline is missing, the potential participant can be enrolled with an estimated baseline, but only if there is no past medical history of chronic kidney disease.
  • If the AKI RS PI believes that the baseline serum creatinine under or over-estimates baseline, a unanimous vote of AKI site PIs can confirm eligibility based on a review of deidentified serum creatinine values provided by the site PI.

AND ONE of the following criteria must be met:

  • Drop in urine output (<500 ml/24 hours)
  • Any rise in serum creatinine ≥0.3 mg/dl over the baseline serum creatinine
  • A rise in serum creatinine >0.1 mg/dl in a patient with high risk of AKI and at least one of the following:
  • Positive kidney injury urine biomarker, as defined by any of the following: ▪ NGAL level greater than or equal to 150 ng/mL by ELISA or clinical analyzer
  • KIM1 level greater than or equal to 2.8 ng/mL by ELISA
  • TIMP2 x IGFBP7 greater than or equal to 2.0 by NephroCheck®
  • Urine microscopy suggestive of acute tubular necrosis defined as a urine microscopy score of greater than or equal to 2. [25] ▪ greater than or equal to 1 Renal Tubular Epithelial cells (RTE) per high powered field (HPF) AND greater than or equal to 1 granular cast/ low powered field (LPF); or
  • greater than or equal to 5 Renal Tubular Epithelial cells (RTE) per high powered field (HPF); or
  • greater than or equal to 5 granular cast/ low powered field (LPF)

Type 1 Diabetes Inclusion Criteria Clinical diagnosis of T1D without evidence of other diabetes types (monogenic, secondary to pancreas disease, etc.), reviewed and approved by KPMP site endocrinologist, and supported by at least one of the following: One or more positive antibodies associated with T1D • Low C-peptide, defined as at least one of the following:

  • Prior/historical test undetectable (below lower limit of assay)
  • C peptide <0.6 ng/ml if estimated glomerular filtration rate (eGFR) ≥60 mL/min per 1.73m2 and use of multiple daily insulin injections or insulin pump use for >1 year
  • C peptide <2.0 ng/ml if eGFR <60 mL/min per 1.73m2 and use of multiple daily insulin injections or insulin pump use for >1 year
  • Diabetes mellitus diagnosis for 5 years and complex insulin defined by multiple daily insulin injections ( 3 or more) or basal insulin injection plus inhaled insulin for meals or insulin pump therapy > 1 year continuously

AND one of the following (CKD, at risk of CKD, or DM-R):

  • CKD: Evidence of persistent kidney damage, manifest as any of the following present on at least two clinic assessments prior to enrollment and at least 3 months apart and excluding people with acute medical illnesses and changing kidney function: o eGFR 30-59 mL/min per 1.73m2 or
  • eGFR greater than or equal to 30 mL/min per 1.73m2 with urine albumin excretion greater than or equal to 30 mg/g creatinine (or mg/day)
  • eGFR greater than or equal to 30 mL/min per 1.73m2 with urine protein excretion greater than or equal to 150 mg/g creatinine (or mg/day)
  • Note: Most recent eGFR must be within the past year and be ≥30 mL/min per 1.73m2 .
  • Note: Most recent urine albumin/creatinine or urine protein/creatinine must be within the past year.
  • At risk of CKD: defined by any one or more of the following:
  • Age <40 years and eGFR 60-75 mL/min per 1.73m2 (persistent eGFR <75 mL/min per 1.73m2
  • at least 3 months apart and including the most recent measurement prior to screening, but not persistently <60 mL/min per 1.73m2 )
  • eGFR slope <-5 mL/min/1.73m2 per year, calculated using all available outpatient serum creatinine values over ≥3 years prior to screening, excluding those obtained during acute illness, and including ≥1 creatinine measurement ≥3 years prior to screening
  • HbA1c ≥8% on 2 occasions and T1D duration ≥5 years
  • Hypertension as defined by KPMP protocol (for hypertension and CKD cohort)
  • UACR ≥10 mg/g (twice, at least 3 months apart)
  • BMI ≥30 kg/m2 with dyslipidemia (defined as triglycerides (TG) ≥150 mg/dL, high-density lipoprotein (HDL) <40/50 mg/dL for men/women, or TG/HDL ratio >3) or lipid lowering treatment
  • sTNFR1 >870 pg/mL
  • DM-R: defined by all of the following:
  • T1D for over 25 years
  • Estimated glomerular filtration rate greater than or equal to 60 mL/min per 1.73m2
  • Urine albumin excretion less than 30 mg/g creatinine (or mg/day)

DM-R Inclusion Criteria A special population of people with long-standing type 1 diabetes (>25 years) who remain free of clinically-evident DKD (i.e. DKD "resilient" or "DM-R" individuals) will also be included. Study of the DKD resilient population using KPMP protocols offers a unique opportunity to identify protective factors against complications of diabetes mellitus. Diabetic Kidney Disease Resilient individuals are defined as individuals with diabetes for more than 25 years that are free from clinical nephropathy

  • Type 1 diabetes for over 25 years
  • Estimated glomerular filtration rate greater than or equal to 60 mL/min/1.73m2
  • Urine albumin excretion less than 30 mg/d (or mg/g creatinine)

General Exclusion Criteria

  • Under 18 years of age
  • Severe allergy to iodinated contrast
  • Pregnancy
  • Transplant recipient (includes solid transplant and bone marrow)
  • Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study)
  • Inability to provide informed consent
  • Clinical diagnosis of kidney disease from an autoimmune disease, dysproteinemia, viral disease or glomerular disease other than DKD or H-CKD
  • Unwilling to receive blood transfusion (if needed)

Safety Exclusion Criteria:

Potential participants will be excluded if the risk of kidney biopsy is considered too high by either the clinicians caring for the potential participant or the investigators at the RS.

Anatomic or Imaging Exclusion Criteria Kidney depth more than 13 cm (percutaneous biopsies only)

  • Kidney size less than 8 cm (percutaneous biopsies only)
  • Solitary or single functioning kidney
  • Evidence of urinary tract obstruction or hydronephrosis
  • Multiple bilateral kidney cysts that will interfere with the safe performance of the biopsy
  • Kidney infection, peri-renal infection, or cutaneous infection that overlies the kidney (percutaneous biopsies only)
  • Any other imaging abnormality, which in the judgement of the operator, prevents biopsy being performed safely.

Bleeding Risk Exclusion Criteria

  • International Normalized Ratios (INR) greater than 1.4
  • Platelet count less than 100,000/uL
  • Hemoglobin less than 8.5 g/dL
  • Chronic anticoagulation
  • Inability to withdraw aspirin, clopidogrel, cilostazol, or similar anti-platelet agents for at least 7 days prior to biopsy (unless bleeding time is normal before open surgical biopsy); clinical judgement will be used in the case of nonsteroidal anti-inflammatory drugs (NSAID) exposure occurring less than 7 days before percutaneous biopsy.
  • Blood pressure of more than 160 mmHg systolic or 100 mmHg diastolic. ○ Peri-procedure blood pressure fluctuations between 140-160 mmHg systolic and 90-100 mmHg diastolic require management, ideally to target, based on clinician/investigator judgment.
  • Ventilator-dependent patient (does not apply to open biopsies)
  • Hypotension or pressor support requirement (does not apply to open biopsies)
  • Any other condition where in the judgement of the operator, biopsy cannot be performed safely.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ashveena Dighe, MS, MPH contact

800-555-5555

ashveena.dighe@mssm.edu

Kristina Blank, MPH contact

206-897-1957

blankk@uw.edu

13 sites in 1 country

United States13 sites, 13 recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Pam Corona, MD, 410-502-3852, kpmprc-jhmi@uw.edu

    Chirag Parikh, MD, PhD

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02115

    Courtney Huynh, 800-555-5555, KPMPrc-bmc@uw.edu

    Sushrut Waikar, MD

    Recruiting

  • Joslin Diabetes Center

    Boston, Massachusetts, 48374

    Jenny Molina-Guzman, 617-309-4130, kpmprc-joslin@uw.edu

    Sylvia Rosas, MD

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Sora Lee, 800-555-5555, KPMPrc-unc@uw.edu

    Amy Mottl, MD

    Recruiting

  • University of Illinois Chicago

    Chicago, Illinois, 60607

    Eunice Carmona-Powell, KPMPrc-uic@uw.edu

    James Lash, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Dianna Sendrey, 216-444-4650, kpmprc-ccf@uw.edu

    John Sedor, MD

    Recruiting

  • University of Texas at Southwestern

    Dallas, Texas, 75390

    Shihong Ma, (214) 645-8291, kpmprc-utsw@uw.edu

    Nancy Wang, 214-645-8267, Zhengnan.Wang@UTSouthwestern.edu

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Michelle Snyder, 800-555-5555, KPMPrc-umn@uw.edu

    Patrick Nachman, MD

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Angela Victoria-Castro, MD, (203) 737-1787, kpmprc-yale@uw.edu

    Melissa Shaw, (203) 737-1787, melissa.m.shaw@yale.edu

    Recruiting

  • Mount Sinai

    New York, New York, 10029

    Lorraine Evo-Ortega, 800-555-5555, KPMPrc-mssm@uw.edu

    Steven Coca, DO

    Recruiting

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905

    Ravinder Kaur, 800-555-5555, kaur.ravinder@mayo.edu

    Aleksandra Kukla, MD

    Recruiting

  • University of Washington

    Seattle, Washington, 98195

    Dawn Lum, 800-555-5555, lumd@uw.edu

    Petter Bjornstad, MD

    Recruiting

  • University of Arizona

    Tucson, Arizona, 85721

    Celina Sanora, 800-555-5555, KPMPrc-arizona@uw.edu

    Frank "Chip" Brosius, MD

    Recruiting

Other trials in United States

About this study

Acute kidney injury (AKI) and chronic kidney disease (CKD) impose a significant global health burden. Yet, no effective therapies currently exist for AKI, and only a few are available for CKD.

Despite significant effort from industry and academia, development of pharmacologic therapies for AKI and CKD has been hampered by:

Read more

Non-predictive animal models The inability to identify and prioritize human targets The limited availability of human kidney biopsy tissue A poor understanding of AKI and CKD heterogeneity Historically, AKI and CKD have been described as single, uniform diseases. However, growing consensus suggests that different disease pathways lead to different subgroups of AKI and CKD (AKIs and CKDs).

Access to human kidney biopsy tissue is a critical first step to define disease heterogeneity and determine the precise molecular pathways that will facilitate identification of specific drug targets and ultimately enable individualized care for people with AKI and CKD.

A number of research centers across the United States are collaborating to bring state-of-the-art technologies together to:

  • Ethically obtain and evaluate kidney biopsies from participants with AKI or CKD
  • Define disease subgroups
  • Create a kidney tissue atlas
  • Identify critical cells, pathways, and targets for novel therapies

The KPMP is made up of three distinct, but highly interactive, activity groups:

  • Recruitment Sites: The recruitment sites (RS) are responsible for recruiting participants with AKI or CKD into the longitudinal study and performing the kidney biopsy.
  • Tissue Interrogation Sites: The tissue interrogation sites (TIS) are responsible for developing and using innovative technologies to analyze the biopsy tissue.
  • Central Hub: The central hub is responsible for aggregating, analyzing, and visualizing the generated data and providing scientific, infrastructure, and administrative support for the KPMP consortium.
Read the detailed description

The Kidney Precision Medicine Project (KPMP) is a prospective cohort study, whose goal is to use deep molecular phenotypes of kidney biopsies, along with longitudinally collected clinical phenotypic data, in order to develop new disease ontologies, classification systems, and treatments for acute kidney injury (AKI) and chronic kidney disease (CKD). Since its inception, the KPMP has sought out and included substantive patient-representative feedback regarding disease experience, lack of innovation in new kidney disease therapies and patient tolerance for risk levels in balance with potential benefits both to the individual and society.

The KPMP Has publicly and operationally committed itself to always put participants and their best interests first and this foundational principle informs and undergirds every facet of the study. Both AKI and CKD are conditions that impose a significant global health burden. Yet, no effective therapies currently exist for AKI, and only a few are available for CKD. The network will utilize state-of-the-art methods to perform molecular interrogation of the tissue and to link the molecular data to kidney structure and clinical information in the form of a kidney tissue atlas.

Molecular and imaging data derived from kidney tissue will be integrated with clinico-pathologic and genetic information, as well as other data derived from analyses of fluid biospecimens, including peripheral blood, urine, and stool. Using advanced analytics to integrate the data, KPMP will aim to define kidney disease subgroups in molecular terms by identifying critical cells, pathways and targets for novel therapies.

Patients with AKI or CKD will be recruited from clinical care encounters (e.g., clinic visits for CKD patients, hospitalization or emergency room visits for AKI patients) and from electronic resources (e.g., existing registries, electronic health records). All study procedures are designed to optimize participant safety and will be ethically conducted, ensuring subjects fully understand the scope of the study and any possible risks.

For each participant, kidney tissue will be obtained for molecular phenotyping and clinical diagnosis. The diagnostic interpretation will be returned to the participant's primary caregiver to inform clinical care, but no treatment interventions will be prescribed by the KPMP. In addition to kidney biopsy, the study will involve collection of baseline (time of biopsy) and longitudinal biospecimens (including urine, plasma, serum, DNA and stool) and demographic, clinical, and laboratory data. Participants will be followed through scheduled in-person and remote (telephone) study visits, as well as through periodic review of electronic health records.

Being tested
Kidney Biopsy, MRI, Retina Scan
Medical subject headings
Acute Kidney Injury, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 1

What participants receive

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

  • Kidney BiopsyProcedure or surgery

    A kidney biopsy is a procedure that involves taking a small piece of kidney tissue for examination with a microscope. A licensed health care provider will perform a kidney biopsy.

  • MRIOther

    Images will be acquired using 3.0T whole body scanner. The participant will undergo a series of sequences (e.g., BOLD, diffusion-weighted, ASL MRI, native T1, and fat fraction sequences). The participant will receive 20 mg of IV furosemide as a bolus. BOLD MRI sequences will be repeated 15 minutes after furosemide administration. ASL sequences are acquired using investigational protocols that are not FDA-approved. Siemens machines will use Body ASL PCASL Perfusion WIP 1023, Phillips will use Body ASL 2D PCASL Perfusion software, and GE machines will use Body ASL PCASL Perfusion software.

  • Retina ScanOther

    Fundus photography, fluorescein angiography, optical coherence tomography, optical coherence tomography angiography, and ophthalmologic exam and history will take place during one retina study visit. The retina visit will take place up to 6 weeks prior to the KPMP kidney biopsy OR up to 8 weeks post-biopsy.

Study groups in NCT04334707
Study groupRoleWhat they receive
Acute Kidney Injury CohortThe focus will be on acute intrinsic non-glomerular disease, primarily on acute tubular necrosis (ATN).
Receives: Procedure: Kidney Biopsy
Chronic Kidney Diseases CohortHigh priority populations include CKD in the setting of diabetes (diabetic kidney disease, DKD) and hypertension-associated CKD (H-CKD).
Receives: Procedure: Kidney Biopsy; Other: MRI; Other: Retina Scan
Type 1 Diabetes (T1D)Clinical diagnosis of Type 1 diabetes without evidence of other diabetes types (monogenic, secondary to pancreas disease, etc.) and has or is at risk of CKD.
Receives: Procedure: Kidney Biopsy; Other: MRI; Other: Retina Scan
Diabetes Mellitus-Resistant (DM-R)Diabetes Mellitus-Resistant: A special population of people with long-standing type 1 diabetes (more than 25 years) who remain free of clinically-evident DKD will also be included.
Receives: Procedure: Kidney Biopsy; Other: Retina Scan

What is being measured

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

  1. Biopsy-related outcomes

    Biopsy-related complications will be collected by KPMP study staff using standardized case report forms. Clinical utility of the biopsy results will be assessed using standardized surveys of clinical providers, and participant-reported outcomes will be assessed using standardized questionnaires. Biopsy-related outcomes data will be collected around the time of the biopsy and within the six months following procurement of the kidney biopsy.

    Measured: Immediately after the procedure for up to 6 months

  2. Kidney disease progression outcomes

    Longitudinal change in estimated glomerular filtration rate (eGFR):

    • Primary composite longitudinal outcome, defined by any of the following:
    • ESRD, defined as initiation of maintenance dialysis or kidney transplantation
    • Sustained decline in eGFR by 40% or more from baseline
    • Individual components of the primary composite outcome
    • Slope of eGFR change (from baseline to the latest value)

    Measured: Through study completion (up to 10 years, depending on enrollment date of participant)

  3. Kidney disease progression outcomes

    Longitudinal change in urine albumin excretion defined by the following:

    -Slope of change in urine albumin-creatinine ratio

    Measured: Through study completion (up to 10 years, depending on enrollment date of participant)

  4. Kidney disease progression outcomes

    Longitudinal change in urine albumin excretion defined by the following:

    -Change of Kidney Disease Improving Global Outcomes (KDIGO) albuminuria stage

    Measured: Through study completion (up to 10 years, depending on enrollment date of participant)

Timeline

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

  1. First posted6 Apr 2020
  2. Study start1 Sep 2019
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04334707
Sponsor's protocol ID
STUDY-24-01176
Other IDs
U2CDK114886, UH3DK114861, UH3DK114866, UH3DK114870, UH3DK114908, UH3DK114915, UH3DK114926, UH3DK114907
Acronym
KPMP
Status last verified
Mar 2026
First submitted
23 Mar 2020
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Available data can be found at https://www.kpmp.org/available-data. All KPMP data is available for sharing.

Publications

  • de Boer IH, Alpers CE, Azeloglu EU, Balis UGJ, Barasch JM, Barisoni L, Blank KN, Bomback AS, Brown K, Dagher PC, Dighe AL, Eadon MT, El-Achkar TM, Gaut JP, Hacohen N, He Y, Hodgin JB, Jain S, Kellum JA, Kiryluk K, Knight R, Laszik ZG, Lienczewski C, Mariani LH, McClelland RL, Menez S, Moledina DG, Mooney SD, O'Toole JF, Palevsky PM, Parikh CR, Poggio ED, Rosas SE, Rosengart MR, Sarwal MM, Schaub JA, Sedor JR, Sharma K, Steck B, Toto RD, Troyanskaya OG, Tuttle KR, Vazquez MA, Waikar SS, Williams K, Wilson FP, Zhang K, Iyengar R, Kretzler M, Himmelfarb J; Kidney Precision Medicine Project. Rationale and design of the Kidney Precision Medicine Project. Kidney Int. 2021 Mar;99(3):498-510. doi: 10.1016/j.kint.2020.08.039.

    PubMed 33637194

  • USGAO, Kidney disease research funding and priority setting. 2017: [online] https://www.gao.gov/assets/690/681714.pdf.

  • RM, B., Social security amendments of 1972: summary and legislative history. 1973

  • Rettig RA. Special treatment--the story of Medicare's ESRD entitlement. N Engl J Med. 2011 Feb 17;364(7):596-8. doi: 10.1056/NEJMp1014193. No abstract available.

    PubMed 21323539

  • CfMaM., S., Chronic Conditions among medicare beneficiaries. Chartbook, 2012 Edition. Baltimore 2012.

  • Norris KC, Williams SF, Rhee CM, Nicholas SB, Kovesdy CP, Kalantar-Zadeh K, Ebony Boulware L. Hemodialysis Disparities in African Americans: The Deeply Integrated Concept of Race in the Social Fabric of Our Society. Semin Dial. 2017 May;30(3):213-223. doi: 10.1111/sdi.12589. Epub 2017 Mar 9.

    PubMed 28281281

  • Prevention, C.f.D.C.a., National Chronic Kidney Disease Fact Sheet, 2017, U.D.o.H.a.H. Services, Editor. 2017: Atlanta, GA.

  • Mendu ML, Erickson KF, Hostetter TH, Winkelmayer WC, Olan G, Meyer RN, Hakim R, Sedor JR. Federal Funding for Kidney Disease Research: A Missed Opportunity. Am J Public Health. 2016 Mar;106(3):406-7. doi: 10.2105/AJPH.2015.303009. No abstract available.

    PubMed 26885959

  • Linde PG, Archdeacon P, Breyer MD, Ibrahim T, Inrig JK, Kewalramani R, Lee CC, Neuland CY, Roy-Chaudhury P, Sloand JA, Meyer R, Smith KA, Snook J, West M, Falk RJ. Overcoming Barriers in Kidney Health-Forging a Platform for Innovation. J Am Soc Nephrol. 2016 Jul;27(7):1902-10. doi: 10.1681/ASN.2015090976. Epub 2016 Apr 28.

    PubMed 27127187

  • Inrig JK, Califf RM, Tasneem A, Vegunta RK, Molina C, Stanifer JW, Chiswell K, Patel UD. The landscape of clinical trials in nephrology: a systematic review of Clinicaltrials.gov. Am J Kidney Dis. 2014 May;63(5):771-80. doi: 10.1053/j.ajkd.2013.10.043. Epub 2013 Dec 6.

    PubMed 24315119

  • Hsu RK, McCulloch CE, Dudley RA, Lo LJ, Hsu CY. Temporal changes in incidence of dialysis-requiring AKI. J Am Soc Nephrol. 2013 Jan;24(1):37-42. doi: 10.1681/ASN.2012080800. Epub 2012 Dec 6.

    PubMed 23222124

  • Lameire NH, Bagga A, Cruz D, De Maeseneer J, Endre Z, Kellum JA, Liu KD, Mehta RL, Pannu N, Van Biesen W, Vanholder R. Acute kidney injury: an increasing global concern. Lancet. 2013 Jul 13;382(9887):170-9. doi: 10.1016/S0140-6736(13)60647-9. Epub 2013 May 31.

    PubMed 23727171

  • Collister D, Pannu N, Ye F, James M, Hemmelgarn B, Chui B, Manns B, Klarenbach S; Alberta Kidney Disease Network. Health Care Costs Associated with AKI. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1733-1743. doi: 10.2215/CJN.00950117. Epub 2017 Oct 19.

    PubMed 29051143

  • Kellum JA, Bellomo R, Ronco C. Kidney attack. JAMA. 2012 Jun 6;307(21):2265-6. doi: 10.1001/jama.2012.4315. No abstract available.

    PubMed 22572776

  • USRDS, United States Renal Data Systems 2013 Annual Data Report. United States Renal Data Systems. 2013: [online] http://http://www.usrds.org/2013/pdf/v1_ch6_13.pdf.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Failure and Acute Kidney Insufficiency, run by Icahn School of Medicine at Mount Sinai at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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 Ashveena Dighe, MS, MPH (800-555-5555, ashveena.dighe@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biopsy-related outcomes (time frame: Immediately after the procedure for up to 6 months). The study lists 4 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 NCT04334707, which also lists 28 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 14 Apr 2026.

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