Kidney Precision Medicine Project

Conditions

• Acute Kidney Failure
• Acute Kidney Insufficiency
• Acute Renal Failure
• Acute Renal Injury
• Acute Renal Insufficiency
• Chronic Kidney Diseases
• Chronic Kidney Insufficiency
• Chronic Renal Diseases
• Chronic Renal Insufficiency
• Kidney Failure, Acute
• Kidney Insufficiency, Acute
• Kidney Insufficiency, Chronic
• Renal Failure, Acute
• Renal Insufficiency, Acute
• Type 1 Diabetes (T1D)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Kidney Biopsy — 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.
• MRI — OTHER
  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 Scan — OTHER
  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 Details

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.

Key Dates

Start date

Sep 1, 2019

Status verified

Mar 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: Acute Kidney Injury Cohort
  The focus will be on acute intrinsic non-glomerular disease, primarily on acute tubular necrosis (ATN).
• Arm: Chronic Kidney Diseases Cohort
  High priority populations include CKD in the setting of diabetes (diabetic kidney disease, DKD) and hypertension-associated CKD (H-CKD).
• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Biopsy-related outcomes [ Time Frame: Immediately after the procedure for up to 6 months ]

Central Contacts

• Ashveena Dighe, MS, MPH
  800-555-5555
  [email protected]
• Kristina Blank, MPH
  206-897-1957
  [email protected]

Locations (13)

Find similar trials in Tucson, AZ

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