Collection of Pooled Uremic Serum for In Vitro Models

Study on How Uremia Affects Heart Cells

K
Kenneth Lim

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase N/A
40 participants needed

Brief description of study

The purpose of the study is to collect human serum from patients with uremia and healthy volunteers that will be used to create physiologically relevant cell culture models. These models will be used to study the impact of uremia on cardiovascular cells.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Recruitment will target uremic patients with advanced CKD (CKD stages 4-5D) or those with acute kidney injury (AKI) from our ambulatory CKD clinics or inpatient general nephrology services at our Academic Health Center (AHC). Patients from our ambulatory CKD clinics or inpatient general nephrology services at our Academic Health Center (AHC), as well as healthy ambulatory volunteers that satisfy inclusion and exclusion criteria and agree to participate will be consented by the research team; they may also be identified through the Musculoskeletal Function, Imaging and Tissue Resource Core (FIT) Core study, IRB number 170755085..The potential subjects will be contacted by phone or in-person by study staff during their inpatient stay or encounter at the ambulatory outpatient clinic. Information about the study may be discussed with interested potential subjects by research personnel via phone, email or in-person as preferred by the subject.

Detailed description of study

The overall objective of this project is to collect human serum from patients with uremia and healthy volunteers. The serum will be pooled by group and utilized in 2-D and 3-D cell or organoid culture experiments to study the response of uremia on cardiac remodeling. Uremic serum will be collected from patients with advanced CKD (CKD stages 4-5D) or those with acute kidney injury (AKI) from our ambulatory CKD clinics or inpatient general nephrology services at IU Health. Serum from healthy ambulatory volunteers will be collected as a negative control.

The procedures of informed consenting and venipuncture/blood draw will occur at IU University Hospital or IU Methodist Hospital.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Uremia, Chronic Kidney Disease (CKD), Acute Kidney Injury (AKI)
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria
•    All study participants:
o    Adult participants and patients aged 18 years or older.
o    All races and ethnicities.
o    All sexes and genders.


•    Uremic group:
o    Patients with advanced CKD:
    CKD Stage 4: eGFR 15-29 mL/min/1.73m2.
    CKD Stage 5: eGFR <15 mL/min/1.73m2 not on dialysis.
    CKD Stage 5D: eGFR <15 mL/min/1.73m2 and dialysis-dependent (any vintage).


o    Patients with AKI based on KDIGO criteria fulfilling one of the following:
    Increase in serum creatinine ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours.
    Increase in serum creatinine 1.5x higher than baseline creatinine levels of the prior 7 days.
    Urine volume output <0.5 mL/kg/h for at least 6 hours.
o    Blood Urea Nitrogen (BUN) levels >20 mg/dL

Exclusion Criteria
•    All study participants:
o    Malignancy requiring chemotherapy or metastatic disease.
o    Pregnancy or breastfeeding.
•    Uremic group:
o    Patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
o    Patients with anti-glomerular basement membrane (GBM) antibody-associated vasculitis.
•    Healthy control group:
o    History of major metabolic disease (e.g., type I and type II diabetes, thyroid disorders), neuromuscular disease (e.g., cervical spondylotic radiculomyelopathy, lumbar spondylosis, amyotrophic lateral sclerosis, Guillain-Barré syndrome, and acquired demyelinating polyneuropathies), cardiovascular disease (e.g., >stage II hypertension, heart failure, myocardial infarction/ischemia) , significant myocardial or pericardial diseases (e.g. amyloidosis, constriction), moderate or severe valvular disease, pulmonary/respiratory disease (e.g., asthma, chronic bronchitis, emphysema, chronic obstructive pulmonary disease), renal disease, liver disease, or anemia
o    Active implanted medical devices (e.g. cardiac pacemaker, defibrillators)

This study investigates the collection of human serum from patients with uremia and healthy volunteers to create cell culture models. Uremia is a condition where waste products build up in the blood because the kidneys are not working properly. The purpose of this study is to understand how uremia affects cardiovascular cells by using these models.

Participants will undergo procedures such as informed consent and blood draws at specified hospitals. The collected serum will be used in laboratory experiments to study cardiac remodeling, which is how the heart changes in response to injury or stress. Blood from healthy volunteers will serve as a comparison to understand the effects of uremic serum.

  • Who can participate: Adults aged 18 and older of any race, ethnicity, sex, or gender can participate. Eligible participants include those with advanced chronic kidney disease stages 4-5D or acute kidney injury, and healthy individuals without significant medical conditions.
  • Study details: Participants will have their blood drawn at specific hospitals. The serum collected will be used for laboratory research to study heart changes.
Updated on 18 May 2026. Study ID: NEPH-IIR-31198, 31198
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only