Kidney Precision Medicine Project (KPMP)

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Acute Renal Failure; Acute Renal Injury; Acute Kidney Failure; Chronic Renal Insufficiency; Kidney Failure, Acute; Renal Insufficiency, Acute; Acute Renal Insufficiency; Acute Kidney Insufficiency; Renal Failure, Acute; Chronic Kidney Insufficiency; Chronic Renal Diseases; Kidney Insufficiency, Chronic; Kidney Insufficiency, Acute
• Intervention / Treatment: Procedure: Kidney Biopsy

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Ashveena Dighe, MS, MPH; Phone Number: 206-744-4029; Email: ashveena@nephrology.washington.edu
• Study Contact Backup: Name: Kristina Blank, MPH; Phone Number: 206-897-1957; Email: blankk@uw.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University
      • Contact: Tanima Arora, MD; Phone Number: 203-640-6196; Email: tanima.arora@yale.edu
      • Contact: Ugochukwu Ugwuowo, MD; Phone Number: 203-809-2766; Email: ugochukwu.ugwuowo@yale.edu
      • Principal Investigator: Frances (Perry) Wilson, MD
      • Sub-Investigator: Dennis Moledina, MBBS, PhD
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University
      • Contact: Pam Corona, MD; Phone Number: 410-502-3852; Email: pamelacorona@jhmi.edu
      • Contact: Rubab Malik; Phone Number: 443-287-2771; Email: rmalik9@jhu.edu
      • Principal Investigator: Chirag Parikh, MD, PhD
      • Sub-Investigator: Steve Menez, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham & Women's Hospital
      • Contact: Zoe Kibbelaar; Phone Number: 617-525-8445; Email: zkibbelaar@bwh.harvard.edu
      • Contact: Mia Colona; Email: mia.colona@bmc.org
    • Boston, Massachusetts, United States, 48374
      • Recruiting
      • Joslin Diabetes Center
      • Contact: Alison Slack; Phone Number: 617-309-4130; Email: Alison.Slack@joslin.harvard.edu
      • Contact: Neil Roy, MBBS; Phone Number: 617-309-6165; Email: Neil.Roy@joslin.harvard.edu
      • Principal Investigator: Sylvia Rosas, MD
      • Sub-Investigator: Stewart Lecker, MD
  • New York
    • New York, New York, United States, 10027
      • Recruiting
      • Columbia University
      • Contact: Karla Mehl, MD; Phone Number: 212-851-5216; Email: km3246@cumc.columbia.edu
      • Contact: Olivia Balderes; Phone Number: 212-851-5216; Email: ob2214@cumc.columbia.edu
      • Principal Investigator: Andrew Bomback, MD
      • Principal Investigator: Krzysztof Kiryluk, MD
      • Principal Investigator: Jonathan Barasch, MD, PhD
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Leslie Cooperman, RN; Phone Number: 216-444-7954; Email: cooperl2@ccf.org
      • Contact: Dianna Sendrey; Phone Number: 216-444-4650; Email: jefferv@ccf.org
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Contact: Tina Vita; Email: vitatm@upmc.edu
      • Contact: James Winters; Email: wintersj4@upmc.edu
      • Principal Investigator: Paul Palevsky, MD
      • Principal Investigator: Matthew Rosengart, MD, MPH
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas at Southwestern
      • Contact: Nancy Wang, RN; Phone Number: 214-645-8267; Email: Zhengnan.Wang@UTSouthwestern.edu
      • Contact: Francisco Sanchez; Email: Francisco.Sanchez@utsouthwestern.edu
      • Principal Investigator: Miguel Vazquez, MD
      • Principal Investigator: Robert Toto, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 subjects with acute medical illnesses and changing kidney function:

  • Estimated glomerular filtration rate 30-59 mL/min/1.73m2
  • Estimated glomerular filtration rate greater than or equal to 60 mL/min/1.73m2 with urine albumin excretion greater than or equal to 30 mg/g creatinine (or mg/day)
  • Estimated glomerular filtration rate greater than or equal to 60 mL/min/1.73m2 with urine protein excretion greater than or equal to 150 mg/g creatinine (or mg/day)

Hypertension-associated Chronic Kidney Disease (H-CKD) Inclusion Criteria

• 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 subjects 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 or proteinuria less than 2000 mg/g creatinine (or mg/day)
  • Estimated glomerular filtration rate greater than or equal to 60 mL/min/1.73m2 with urine albumin excretion 30-2000 mg/g creatinine (or mg/day)
  • Estimated glomerular filtration rate greater than or equal to 60 mL/min/1.73m2 with urine protein excretion 150-2000 mg/g creatinine (or mg/day)

Acute Kidney Injury Subjects Inclusion Criteria

All three of the following criteria must be met:

• 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 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.
• Elevated serum creatinine (greater than or equal to 1.5 times baseline as defined above).

• And at least ONE of the following:

  • A repeat serum creatinine within 48 hours of initial serum creatinine, showing a further increase of 0.3 mg/dL

  • 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.

    • 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)

General Exclusion Criteria:

• Under 18 years of age
• Body Mass Index (BMI) greater than 40 kg/m2
• Allergy to iodinated contrast (any reaction)
• Pregnancy
• Malignancy - Receiving active chemotherapy or radiation to treat malignancy (except for nephrectomy tissue for reference and feasibility studies)
• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute Kidney Injury Cohort; 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.	Procedure: Kidney Biopsy; 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.; Other Names: Renal Biopsy; Laparotomy
Chronic Kidney Diseases Cohort; 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.	Procedure: Kidney Biopsy; 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.; Other Names: Renal Biopsy; Laparotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after the procedure for up to 6 months
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)	Through study completion (up to 10 years, depending on enrollment date of participant)
Kidney disease progression outcomes	Longitudinal change in urine albumin excretion defined by the following: -Slope of change in urine albumin-creatinine ratio	Through study completion (up to 10 years, depending on enrollment date of participant)
Kidney disease progression outcomes	Longitudinal change in urine albumin excretion defined by the following: -Change of Kidney Disease Improving Global Outcomes (KDIGO) albuminuria stage	Through study completion (up to 10 years, depending on enrollment date of participant)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Additional Outcome Measures	All-cause mortality, defined by death from any cause and validated through linkages with the National Death Index (NDI); Cardiovascular events, including heart failure, myocardial infarction, cerebrovascular event, transient ischemic attack, thromboembolic event, arrhythmia, and cardiac arrest; New AKI events after KPMP enrollment; Hospital admissions and discharge diagnoses after KPMP enrollment	Through study completion (up to 10 years, depending on enrollment date of participant)
Number of Participants with Outcomes Specific to AKI	Duration of AKI: number of days with elevated serum creatinine above baseline; Recovery of AKI: return of serum creatinine to greater than 125% of baseline by 3 months post-biopsy; ICU admissions: admissions to any intensive care unit during hospitalization; Need for dialysis: initiation and duration of any dialysis modality (CRRT, HD, or PD); Length of hospital stay: number of days during initial AKE episode	Through study completion (up to 10 years, depending on enrollment date of participant)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Johns Hopkins University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Washington University School of Medicine; University of California, San Diego; Yale University; Columbia University; Icahn School of Medicine at Mount Sinai; University of Pittsburgh; University of Michigan; The Cleveland Clinic; Brigham and Women's Hospital; University of California, San Francisco; Stanford University; Ohio State University; University of Texas; Indiana University; The University of Texas Health Science Center at San Antonio; Joslin Diabetes Center; Pacific Northwest National Laboratory; Broad Institute; Princeton University; European Molecular Biology Laboratory

Publications and helpful links

General Publications

• 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. Erratum In: N Engl J Med. 2011 Apr 21;364(16):1582.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Waikar SS, Liu KD, Chertow GM. Diagnosis, epidemiology and outcomes of acute kidney injury. Clin J Am Soc Nephrol. 2008 May;3(3):844-61. doi: 10.2215/CJN.05191107. Epub 2008 Mar 12.
• Sileanu FE, Murugan R, Lucko N, Clermont G, Kane-Gill SL, Handler SM, Kellum JA. AKI in low-risk versus high-risk patients in intensive care. Clin J Am Soc Nephrol. 2015 Feb 6;10(2):187-96. doi: 10.2215/CJN.03200314. Epub 2014 Nov 25.
• Murugan R, Karajala-Subramanyam V, Lee M, Yende S, Kong L, Carter M, Angus DC, Kellum JA; Genetic and Inflammatory Markers of Sepsis (GenIMS) Investigators. Acute kidney injury in non-severe pneumonia is associated with an increased immune response and lower survival. Kidney Int. 2010 Mar;77(6):527-35. doi: 10.1038/ki.2009.502. Epub 2009 Dec 23.
• Coca SG, Yusuf B, Shlipak MG, Garg AX, Parikh CR. Long-term risk of mortality and other adverse outcomes after acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Jun;53(6):961-73. doi: 10.1053/j.ajkd.2008.11.034. Epub 2009 Apr 5.
• Waikar SS, Winkelmayer WC. Chronic on acute renal failure: long-term implications of severe acute kidney injury. JAMA. 2009 Sep 16;302(11):1227-9. doi: 10.1001/jama.2009.1364. No abstract available.
• Coca SG, Singanamala S, Parikh CR. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis. Kidney Int. 2012 Mar;81(5):442-8. doi: 10.1038/ki.2011.379. Epub 2011 Nov 23.
• Kellum JA, Sileanu FE, Murugan R, Lucko N, Shaw AD, Clermont G. Classifying AKI by Urine Output versus Serum Creatinine Level. J Am Soc Nephrol. 2015 Sep;26(9):2231-8. doi: 10.1681/ASN.2014070724. Epub 2015 Jan 7.
• AKIWG, K., Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Acute Kidney Injury. Kidney inter., Suppl., 2012. 2: p. 1-138.
• Chu R, Li C, Wang S, Zou W, Liu G, Yang L. Assessment of KDIGO definitions in patients with histopathologic evidence of acute renal disease. Clin J Am Soc Nephrol. 2014 Jul;9(7):1175-82. doi: 10.2215/CJN.06150613. Epub 2014 May 1.
• Perazella MA, Coca SG, Hall IE, Iyanam U, Koraishy M, Parikh CR. Urine microscopy is associated with severity and worsening of acute kidney injury in hospitalized patients. Clin J Am Soc Nephrol. 2010 Mar;5(3):402-8. doi: 10.2215/CJN.06960909. Epub 2010 Jan 14.
• Corapi KM, Chen JL, Balk EM, Gordon CE. Bleeding complications of native kidney biopsy: a systematic review and meta-analysis. Am J Kidney Dis. 2012 Jul;60(1):62-73. doi: 10.1053/j.ajkd.2012.02.330. Epub 2012 Apr 24.
• Rodriguez LL, Brooks LD, Greenberg JH, Green ED. Research ethics. The complexities of genomic identifiability. Science. 2013 Jan 18;339(6117):275-6. doi: 10.1126/science.1234593. No abstract available.
• CfMaM., S., Chronic Conditions among medicare beneficiaries. Chartbook, 2012 Edition. Baltimore 2012.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ANTICIPATED): June 30, 2027
• Study Completion (ANTICIPATED): June 30, 2027

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (ACTUAL): April 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: SITE00000750; U2CDK114886 (NIH); UH3DK114861 (NIH); UH3DK114866 (NIH); UH3DK114870 (NIH); UH3DK114908 (NIH); UH3DK114915 (NIH); UH3DK114926 (NIH); UH3DK114907 (NIH); UH3DK114920 (NIH); UH3DK114923 (NIH); UH3DK114933 (NIH); UH3DK114937 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No