SDCC - Prospective Cohort Study of Chronic Renal Insufficiency

Eligible men and women who consent will be enrolled in this observational study. Participants
will remain under the care of their usual physicians. Questionnaires will be completed and
tests will be conducted that will provide information about aspects of kidney and heart
health status.

Participants are screened over the course of a brief visit during which informed consent is
obtained, height and weight measured, blood drawn and a few forms are completed.

If eligible, a participant will return to the center for a more extensive visit. At the
Baseline Visit the following will occur:

- eligibility is confirmed

- weight, height, waist and body water and fat content are measured by Bioelectrical
Impedance Analysis (BIA)

- blood pressure and heart rate are recorded

- information about medical history and medication used recently

- blood draw (about ½ cup) for the following tests: CBC (Complete Blood Count), tests of
metabolism, and several other heart and kidney tests

- blood pressure in the leg and arm calculated as the Ankle Brachial Index (ABI)

- Electrocardiogram (ECG)

- urine sample and collection of 24-hour urine sample for kidney function testing

- complete questionnaires about quality of life, diet, mood, thought processes and
physical activity

- nail clipping

This visit takes about 3 to 4 hours. Participants will be contacted by telephone six months
after the Baseline Visit to ask about recent medical events and medications.

Participants will be asked to return to the center for annual visits during which many but
not all of the procedures described above will be conducted.

Inclusion Criteria:

During the screening visit a blood sample will be tested to indirectly check kidney
function based on the serum creatinine level:

- Age Range: 45 - 79 years

- Estimated Glomerular Filtration Rate (GFR): 45 - 70 mL/min/1.73m²

- Proteinuria: varies dependent on eGRF

Exclusion Criteria:

- Unable or unwilling to provide informed consent

- Previously received dialysis (peritoneal and/or hemodialysis) lasting more than one
month

- Prior organ or bone marrow transplant

- Prior renal transplant

- Received immunosuppressive or other immunotherapy for primary renal disease or
systemic vasculitis that affects the kidneys (i.e., anti-GCM, ANCA, SLE, IgA
nephropathy, cryoglobulin, etc.) within the past six months before enrollment

- Received chemotherapy or alkylating agents for systemic cancer

- Known cirrhosis

- NYHA Class III or IV heart failure at baseline

- Previous diagnosis of multiple myeloma or renal carcinoma

- Previously diagnosed polycystic kidney disease

- Known HIV infection and/or AIDS

- Pregnant or breast-feeding women

- Currently participating in an interventional clinical trial (i.e., primarily trials of
therapeutic agents that may have an effect on renal or cardiovascular outcomes).

- Institutionalized (e.g., prisoner, nursing home resident, skilled nursing facility
resident)

- Appears unlikely or unable to participate in the required study procedures as assessed
by the investigator, study coordinator or designee.