Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
1000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-09-01
Study Completion Date
2027-06-30
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Acute Kidney Failure
Acute Kidney Insufficiency
Acute Renal Failure
Acute Renal Injury
Acute Renal Insufficiency
Kidney Failure, Acute
Kidney Insufficiency, Acute
Renal Failure, Acute
Renal Insufficiency, Acute
Chronic Kidney Diseases
Chronic Kidney Insufficiency
Chronic Renal Diseases
Chronic Renal Insufficiency
Kidney Insufficiency, Chronic
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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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.
Kidney Biopsy
Intervention Type
PROCEDURE
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.
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.
Kidney Biopsy
Intervention Type
PROCEDURE
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.
Interventions
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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.
Intervention Type
PROCEDURE
Other Intervention Names
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Renal Biopsy
Laparotomy
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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)
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)
* 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)
* 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)
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)
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)
* 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)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Sponsor Role
collaborator
University of Michigan
OTHER
Sponsor Role
collaborator
Icahn School of Medicine at Mount Sinai
OTHER
Sponsor Role
collaborator
Brigham and Women's Hospital
OTHER
Sponsor Role
collaborator
Broad Institute of MIT and Harvard
OTHER
Sponsor Role
collaborator
The Cleveland Clinic
OTHER
Sponsor Role
collaborator
Columbia University
OTHER
Sponsor Role
collaborator
European Molecular Biology Laboratory
UNKNOWN
Sponsor Role
collaborator
Indiana University
OTHER
Sponsor Role
collaborator
Johns Hopkins University
OTHER
Sponsor Role
collaborator
Joslin Diabetes Center
OTHER
Sponsor Role
collaborator
Pacific Northwest National Laboratory
FED
Sponsor Role
collaborator
Princeton University
OTHER
Sponsor Role
collaborator
Stanford University
OTHER
Sponsor Role
collaborator
Ohio State University
OTHER
Sponsor Role
collaborator
University of California, San Diego
OTHER
Sponsor Role
collaborator
University of California, San Francisco
OTHER
Sponsor Role
collaborator
University of Pittsburgh
OTHER
Sponsor Role
collaborator
The University of Texas Health Science Center at San Antonio
OTHER
Sponsor Role
collaborator
University of Texas
OTHER
Sponsor Role
collaborator
Washington University School of Medicine
OTHER
Sponsor Role
collaborator
Yale University
OTHER
Sponsor Role
collaborator
University of Washington
OTHER
Sponsor Role
lead
Responsible Party
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Jonathan Himmelfarb
Professor, School of Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jonathan Himmelfarb, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Yale University
New Haven, Connecticut, United States
Site Status
RECRUITING
Johns Hopkins University
Baltimore, Maryland, United States
Site Status
RECRUITING
Brigham & Women's Hospital
Boston, Massachusetts, United States
Site Status
RECRUITING
Joslin Diabetes Center
Boston, Massachusetts, United States
Site Status
RECRUITING
Columbia University
New York, New York, United States
Site Status
RECRUITING
Cleveland Clinic
Cleveland, Ohio, United States
Site Status
RECRUITING
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Site Status
RECRUITING
University of Texas at Southwestern
Dallas, Texas, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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USGAO, Kidney disease research funding and priority setting. 2017: [online] https://www.gao.gov/assets/690/681714.pdf.
Reference Type
BACKGROUND
RM, B., Social security amendments of 1972: summary and legislative history. 1973
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BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
Prevention, C.f.D.C.a., National Chronic Kidney Disease Fact Sheet, 2017, U.D.o.H.a.H. Services, Editor. 2017: Atlanta, GA.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
AKIWG, K., Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Acute Kidney Injury. Kidney inter., Suppl., 2012. 2: p. 1-138.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
CfMaM., S., Chronic Conditions among medicare beneficiaries. Chartbook, 2012 Edition. Baltimore 2012.
Reference Type
RESULT
Other Identifiers
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SITE00000750
Identifier Type: -
Identifier Source: org_study_id
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SDCC - Prospective Cohort Study of Chronic Renal Insufficiency
NCT00304148
ACTIVE_NOT_RECRUITING
Identification of Patients at Risk of CKD After AKI
NCT05740709
RECRUITING
Decision Support for Detection of Chronic Kidney Disease in Type II Diabetes Mellitus
NCT05342545
COMPLETED
NA
Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease
NCT06322056
RECRUITING
NA
Preventing Acute Kidney Injury
NCT04376619
WITHDRAWN
NA
Chronic Kidney Disease Clinical Decision Support
NCT03890588
COMPLETED
NA
Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence
NCT05937451
NOT_YET_RECRUITING
NA
A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects
NCT01602328
TERMINATED
PHASE2
Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
NCT01209169
COMPLETED
An Observational Study of Patients With Chronic Kidney Disease
NCT05774392
WITHDRAWN
Outpatient Recovery From Acute Kidney Injury Requiring Dialysis - 2
NCT07106151
NOT_YET_RECRUITING
NA
Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease
NCT02863510
COMPLETED
NA
Identification and Validation of Biomarkers of Acute Kidney Injury Recovery
NCT01868724
COMPLETED
National Unified Renal Translation Research Enterprise - Chronic Kidney Disease
NCT04084145
ACTIVE_NOT_RECRUITING
Kidney Health: Eat Well, Live Well
NCT05970341
RECRUITING
NA