CRIC: SDCC - Prospective Cohort Study of Chronic Renal Insufficiency
Study Details
Study Description
Brief Summary
Insights into the cause of kidney failure have emerged from research, but less is known about the epidemiology of less severe forms of kidney disease known both as chronic kidney disease (CKD) or chronic renal insufficiency (CRI).
The Chronic Renal Insufficiency Cohort (CRIC) Study was established to study the consequences of CKD with a particular focus on cardiovascular illness like myocardial infarction (heart attack) and stroke. The CRIC Study will identify high-risk subgroups of individuals with CRI, informing future treatment trials, and development of preventive therapies.
CRIC is an observational study that to date, over 5000 participants have been enrolled in the CRIC cohort. The goal for CRIC 2018 which began in July 2018 is to follow participants for an additional 5 years. To maximize the opportunities inherent in this unique scientific resource, the CRIC Study will, in its next phase, pursue a multifaceted strategy involving: (a) continued follow-up of the cohort and investigation of a broad array of factors associated with the progression and consequences of CKD utilizing state-of-the-art methods in biostatistics and bioinformatics; and (b) the use of novel remote data collection techniques to identify trajectories of kidney function and cardiovascular risk sub-phenotypes.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Previously enrolled participants who reconsent to the next phase. CRIC 2018, 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 who reconsent to this phase will return to the center for a more extensive visit. At the Clinic Visit the following will occur:
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weight is measured
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blood pressure and heart rate are recorded
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information about medical history and medication used recently
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blood draw (about ½ cup) for the following tests: CBC (Complete Blood Count), tests of metabolism, and several other heart and kidney tests
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blood pressure in the leg and arm calculated as the Ankle Brachial Index (ABI)
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urine sample collection for kidney function testing
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complete questionnaires about quality of life, diet, mood, thought processes and physical activity
This visit takes about 1 to 2 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.
Additionally, up to 1500 CRIC participants will be asked to participate in one of two substudies using remote data collection techniques to identify trajectories of kidney function and cardiovascular risk sub-phenotypes.
Trajectories of Kidney Function and Damage Sub-Protocol:
CRIC participants who are eligible and consent to participation in the Trajectories of Kidney Function and Damage Sub-Protocol will be asked to perform monthly fingerstick creatinine testing for 12 months. Participants will also quantify home albuminuria/proteinuria monthly during the same 12-month period using the combined technology of a urine diagnostic dipstick and scan card, and smartphone application. Research study staff will review the home test instructions for both procedures and conduct a practice run of the procedures with the participant to confirm the participant can master the procedures. Participants will be asked to test their urine on the same day as their fingerstick creatinine which will be listed on their personalized calendar, with the same reminder and resupply methods. Prior to testing their urine, participants will be asked to complete a brief survey on risk factors for AKI through the smartphone application.
CV Sub-Phenotyping Sub-Protocol
For CRIC participants who are eligible and consent to participation in the CV Sub-Phenotyping Sub-Protocol (up to 1500) will be fitted in person or remotely with the Zephyr BioPatch and instructed on how to care for it and recharge it. The Zephyr BioPatch consists of a sensor known as the BioModule, which contains a 3-axis accelerometer and a single-lead ECG (EC38 Type 3 ambulatory), sampled at 1KHz. It is powered by a rechargeable battery, with each charge lasting approximately 24 hours. The BioModule is worn using a disposable chest patch. Participants will be asked to wear the BioPatch for two consecutive 24-hour periods. Participants will recharge the BioPatch between these two 24-hour periods. Participants will then return the BioPatch to the clinical center.
To detect the occurrence and burden of atrial fibrillation and other atrial and ventricular dysrhythmias, the study team will fit participants with the ZIO XT Patch (iRhythm Technologies, http://www.irhythmtech.com/products-services/zio-xt), which provides for 14-day continuous, beat-to-beat ECG monitoring and validated arrhythmia detection algorithms. The general procedure for this component of the sub-protocol will be similar to that described for the Zephyr BioPatch. Up to 1500 eligible and willing participants will be fitted in person or remotely with the ZIO XT Patch at their first, second or third annual clinic visit during CRIC 2018. The ZIO XT Patch, which is typically worn on the upper left part of the chest, will be worn continuously for 14 days, after which the participant will mail the patch back to iRhythm Technologies for analysis and reporting back to the SDCC using a prepared mailer distributed to participant at the time patch is affixed.
Participants enrolled in the CV Sub-Phenotyping Sub-protocol may be asked to wear both the Zephyr Biopatch and the ZIO XT Patch at different timepoints but are not required.
Participation in the Trajectories of Kidney Function and Damage sub-protocol will not preclude participation in the CV sub-phenotyping sub-protocol.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
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| CRIC Cohort
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| CRIC Subcohort
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Outcome Measures
Primary Outcome Measures
- The slope of GFR is the primary outcome; Primary outcomes regarding CVD will focus on clinical events indicative of ischemic heart disease, CHF, stroke, and peripheral vascular disease supplemented by radiographic evidence of progressive CVD [5 yrs]
Secondary Outcome Measures
- 1.Onset of ESRD; 2.Significant loss of renal function; 3.Composite clinical outcome defined by the occurrence of either 50% decline, or 25 l/min/1.73 m2 decline in GFR from baseline, or onset of ESRD; 4. Slope of change in proteinuria over time. [5 yrs]
Eligibility Criteria
Criteria
Inclusion Criteria:
During the screening visit a blood sample will be tested to indirectly check kidney function based on the serum creatinine level:
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Age Range: 45 - 79 years
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Estimated Glomerular Filtration Rate (GFR): 45 - 70 mL/min/1.73m²
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Proteinuria: varies dependent on eGRF
Exclusion Criteria:
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Unable or unwilling to provide informed consent
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Previously received dialysis (peritoneal and/or hemodialysis) lasting more than one month
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Prior organ or bone marrow transplant
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Prior renal transplant
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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
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Received chemotherapy or alkylating agents for systemic cancer
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Known cirrhosis
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NYHA Class III or IV heart failure at baseline
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Previous diagnosis of multiple myeloma or renal carcinoma
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Previously diagnosed polycystic kidney disease
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Known HIV infection and/or AIDS
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Pregnant or breast-feeding women
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Currently participating in an interventional clinical trial (i.e., primarily trials of therapeutic agents that may have an effect on renal or cardiovascular outcomes).
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Institutionalized (e.g., prisoner, nursing home resident, skilled nursing facility resident)
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Appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
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| 1 | Kaiser Permanente of Northern California | Oakland | California | United States | 94612 |
| 2 | University of California | San Francisco | California | United States | 94143-0532 |
| 3 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
| 4 | Tulane University Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 5 | University of Maryland Medical System | Baltimore | Maryland | United States | 21201 |
| 6 | Johns Hopkins Medical Institutions | Baltimore | Maryland | United States | 21205 |
| 7 | University of Michigan Hospitals | Ann Arbor | Michigan | United States | 48106 |
| 8 | Wayne State - Harper University Hospital | Detroit | Michigan | United States | 48201 |
| 9 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
| 10 | Metrohealth Medical Center | Cleveland | Ohio | United States | 44109 |
| 11 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 12 | University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- University of Pennsylvania
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Johns Hopkins University
- Case Western Reserve University
- University of Michigan
- University of Illinois at Chicago
- Tulane University
- Kaiser Permanente
Investigators
- Study Director: Harold I. Feldman, M.D., MSCE, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Link to the CRIC Study Website
- The CRIC Study website has a section of general information about the study and kidney disease for members of the general public who may be interested. It includes a brief description of the study and the 13 participating clinical centers.
Publications
- Feldman HI, Appel LJ, Chertow GM, Cifelli D, Cizman B, Daugirdas J, Fink JC, Franklin-Becker ED, Go AS, Hamm LL, He J, Hostetter T, Hsu CY, Jamerson K, Joffe M, Kusek JW, Landis JR, Lash JP, Miller ER, Mohler ER 3rd, Muntner P, Ojo AO, Rahman M, Townsend RR, Wright JT; Chronic Renal Insufficiency Cohort (CRIC) Study Investigators. The Chronic Renal Insufficiency Cohort (CRIC) Study: Design and Methods. J Am Soc Nephrol. 2003 Jul;14(7 Suppl 2):S148-53.
- Stevens LA, Coresh J, Feldman HI, Greene T, Lash JP, Nelson RG, Rahman M, Deysher AE, Zhang YL, Schmid CH, Levey AS. Evaluation of the modification of diet in renal disease study equation in a large diverse population. J Am Soc Nephrol. 2007 Oct;18(10):2749-57. Epub 2007 Sep 12.
- Wimmer NJ, Townsend RR, Joffe MM, Lash JP, Go AS; Chronic Renal Insufficiency Cohort Study Investigators. Correlation between pulse wave velocity and other measures of arterial stiffness in chronic kidney disease. Clin Nephrol. 2007 Sep;68(3):133-43. Erratum in: Clin Nephrol. 2011 Dec;76(6):507.
- DK60990
- U01DK060990