1000 Participants Needed

Kidney Biopsy for Acute and Chronic Kidney Conditions

(KPMP Trial)

Recruiting at 7 trial locations
AD
KB
Overseen ByKristina Blank, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover new treatments for acute kidney injury (AKI) and chronic kidney disease (CKD) by studying kidney tissues. Researchers will take small samples (biopsies) from the kidneys of individuals with these conditions to understand various disease types and identify potential drug targets. Participants with kidney issues due to diabetes or high blood pressure, or those at risk for or experiencing early AKI, are needed.

As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to new treatments for kidney diseases.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that kidney biopsies are safe for participants with AKI or CKD?

Research has shown that kidney biopsies, which help study kidney diseases like acute kidney injury (AKI) and chronic kidney disease (CKD), carry some risks but are generally safe. In people with CKD, the risk of complications from a kidney biopsy increases when kidney function is very low, especially if certain conditions aren't met. Despite this, biopsies are valuable for understanding the root of the problem. One study found that kidney biopsies could cause severe bleeding, but this is rare.

For AKI, research indicates that kidney biopsies can safely provide important information about the condition, such as identifying acute tubular necrosis (a type of kidney damage). However, risks like severe bleeding can occur, though they are uncommon.

Overall, while there are risks, kidney biopsies are usually well-tolerated and offer essential information for treating AKI and CKD. Prospective trial participants should weigh these benefits and risks when considering involvement in studies involving kidney biopsies.12345

Why are researchers excited about this trial?

Researchers are excited about the Kidney Precision Medicine Project because it aims to uncover detailed insights into chronic kidney diseases (CKD) and acute kidney injury (AKI) through kidney biopsies. Unlike standard treatments that often rely on general medication and dialysis, this approach seeks to understand the specific molecular and cellular changes happening in the kidneys. By focusing on high-priority populations, including those with diabetic kidney disease and hypertension-associated CKD, as well as patients with acute tubular necrosis, the project has the potential to develop personalized treatment strategies. Ultimately, this could lead to more effective and targeted therapies, improving outcomes for patients with these complex conditions.

What evidence suggests that kidney biopsy is effective for understanding AKI and CKD?

This trial will examine the role of kidney biopsies in understanding chronic kidney disease (CKD) and acute kidney injury (AKI). Research has shown that kidney biopsies are crucial for identifying specific disease processes, leading to more targeted treatments. Participants in the Chronic Kidney Diseases Cohort, particularly those with diabetes or high blood pressure, will undergo biopsies to aid in disease management and improve health outcomes. Meanwhile, the Acute Kidney Injury Cohort will use biopsies to differentiate between types of kidney injuries, such as acute tubular necrosis, a common cause of AKI. Detailed information from biopsies is essential for creating personalized treatment plans and enhancing patient care.678910

Who Is on the Research Team?

JH

Jonathan Himmelfarb, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

Inclusion Criteria

Chronic Kidney Disease Subjects Inclusion Criteria Diabetic kidney disease (DKD)
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
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment and Biopsy

Participants with AKI or CKD are recruited and undergo kidney biopsy for molecular phenotyping and clinical diagnosis

Immediate
1 visit (in-person)

Longitudinal Data Collection

Collection of baseline and longitudinal biospecimens, including urine, plasma, serum, DNA, and stool, along with demographic, clinical, and laboratory data

Up to 10 years
Scheduled in-person and remote (telephone) visits

Follow-up

Participants are monitored for safety and effectiveness after biopsy, including biopsy-related outcomes and clinical utility assessments

6 months
Periodic review of electronic health records

What Are the Treatments Tested in This Trial?

Interventions

  • Kidney Biopsy

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Chronic Kidney Diseases CohortExperimental Treatment1 Intervention
Group II: Acute Kidney Injury CohortExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Broad Institute of MIT and Harvard

Collaborator

Trials
21
Recruited
16,300+

Broad Institute

Collaborator

Trials
21
Recruited
16,300+

Washington University School of Medicine

Collaborator

Trials
2,027
Recruited
2,353,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Brigham and Women's Hospital

Collaborator

Trials
1,694
Recruited
14,790,000+

University of California, San Diego

Collaborator

Trials
1,215
Recruited
1,593,000+

The Cleveland Clinic

Collaborator

Trials
1,072
Recruited
1,377,000+

University of Pittsburgh

Collaborator

Trials
1,820
Recruited
16,360,000+

Yale University

Collaborator

Trials
1,963
Recruited
3,046,000+

Citations

Clinicopathological Characteristics and Kidney Outcomes ...

Moledina D.G., Parikh C.R. Differentiating acute interstitial nephritis from acute tubular injury: a challenge for clinicians. ... necrosis factor-alpha for ...

Evaluation of acute kidney injury among hospitalized adult ...

Some examples are as follows: •Sepsis or hemorrhage suggests acute tubular necrosis (ATN). •Crush injury or compartment syndrome suggests ...

Deep-learning model for evaluating histopathology of ...

Tubular injury is the most common cause of acute kidney injury ... Acute tubular necrosis and renal failure in patients with glomerular disease.

Acute tubular necrosis - Symptoms, diagnosis and treatment

Renal failure secondary to acute tubular necrosis: epidemiology, diagnosis, and management. Chest. 2005 Oct;128(4):2847-63. Abstract ...

Kidney Precision Medicine Project (KPMP)

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 ...

Safety and Diagnostic Yield of Protocolized Percutaneous ...

Of the 7 biopsies, 6 revealed acute tubular necrosis (ATN) in various histopathologic contexts, 1 patient had severe arteriolar sclerosis and chronic thrombotic ...

5-year data analysis of the Nationwide Inpatient Sample

Acute renal failure. 5845, Acute kidney failure with lesion of tubular necrosis, 15.2. 5846, Acute kidney failure with lesion of renal cortical ...

Expanding the Role for Kidney Biopsies in Acute ...

Bull et al. Renal function studies in acute tubular necrosis. Clin Sci. (1950) ... The major risk of kidney biopsy is severe bleeding. Numerous risk ...

Renal Biopsy Diagnosis of Acute Tubular Injury after Pfizer ...

Histones and neutrophil extracellular traps enhance tubular necrosis and remote organ injury in ischemic AKI. J. Am. Soc. Nephrol. 2017;28 ...

Acute kidney injury in patients treated with immune ...

To identify risk factors for ICPi-AKI, we also collected data on ... tubular necrosis; FSGS, focal segmental glomerulosclerosis; HPF ...