Is NCT04334707 recruiting in Tucson, AZ?

Yes, NCT04334707 is currently recruiting participants at its Tucson, AZ location. This acute kidney failure clinical trial is actively enrolling qualified participants.

How do I join the acute kidney failure clinical trial in Tucson?

To join this clinical trial in Tucson, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Tucson clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Kidney Failure Clinical Trial in Tucson, AZ

About This Acute Kidney Failure Study in Tucson

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.

Sponsor: Icahn School of Medicine at Mount Sinai

Who Can Participate

Inclusion Criteria

Diabetic kidney disease (DKD)

Diagnosis of diabetes mellitus (type 1 or 2) established by at least one of the following criteria: o Hemoglobin A1C greater than or equal to 6.5%, confirmed with a repeat test within the past year o 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 o 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 ) o 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 o HbA1c ≥8% on 2 occasions and T1D duration ≥5 years o Hypertension as defined by KPMP protocol (for hypertension and CKD cohort) o 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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Tucson?

Yes, this clinical trial (NCT04334707) has an active research site in Tucson, AZ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Kidney Failure Treatment Options in Tucson, AZ

If you're searching for acute kidney failure treatment options in Tucson, AZ, this clinical trial (NCT04334707) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Tucson research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acute kidney failure specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute kidney failure clinical trials near you to find additional studies recruiting in your area.

Acute Kidney Failure Clinical Trial in Tucson, AZ

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