SDCC - Prospective Cohort Study of Chronic Renal Insufficiency

Renal Insufficiency, Chronic Clinical Trial

— CRIC  

Official title:

Prospective Cohort Study of Chronic Renal Insufficiency

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00304148
• Other study ID #: DK60990
• Secondary ID: U01DK060990
• Status: Active, not recruiting
• Start date: July 2003
• Est. completion date: June 2028

Study information

• Verified date: July 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic kidney disease (CKD) is a silent epidemic affecting more than 37 million Americans. The burden of morbidity and mortality associated with CKD derives from its frequent progression to end-stage kidney disease (ESKD) and the disproportionate risk of cardiovascular disease (CVD) and associated complications. CKD is strongly and independently associated with CVD, even after adjustment for traditional CVD risk factors. This led to the hypothesis that other risk factors augment the rate of CVD in the setting of CKD. Hence, many patients with progressive renal disease succumb to fatal CVD events before they need renal replacement therapy.

The National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) established the Chronic Renal Insufficiency Cohort (CRIC) Study in 2001 with the initial goal of elucidating the relationship between CKD and CVD. Since its inception, the CRIC Study has recruited and followed a racially and ethnically diverse cohort of over 5,000 participants with reduced kidney function from 13 clinical recruitment sites across the US. The original aim of CRIC was to establish a clinical research laboratory designed to (a) identify novel predictors of CKD progression, and (b) characterize the manifestations of CVD and identify its risk factors among individuals with CKD. The CRIC Study has examined a broad set of etiological factors (clinical, behavioral, and biomarker-associated) potentially responsible for both progressive CKD and CKD-related morbidities, especially those early in the course of CKD. Characterizing relationships between these risk factors and outcomes should facilitate identification of high-risk subgroups with CKD and guide enrollment into preventive treatment trials and application of preventive therapies. Over time, the scientific focus and the CRIC investigator network have broadened extensively through a highly successful ancillary studies program that has included more than 100 projects, most of which have been funded through federal grants. To date, the CRIC Study's investigative activities have resulted in over 300 published scientific papers with many additional manuscripts in development.

Description:

Study Visits and Participant Contact

During its 5th and final phase, the 7 Clinical Centers comprised of 12 sites will extend participant follow-up for participants who have not reached ESKD before the inception of Phase 5 by conducting 2 study visits. For all participants, Visit 1 is conducted in person at the study site. Visit 2 can be conducted in person or by telephone. For participants who enrolled in one or more Phase 4 subprotocols, Visit 2 requires a blood draw for a creatinine measurement. The blood draw can be performed at the study site, at a commercial laboratory, or at the participant's home. The principal focus for these study visits is to ascertain kidney and clinical CVD outcomes, both of which are of particular importance for the participants who enrolled in the three Phase 4 subprotocols. Participants may be contacted at other times during the year to answer additional questions or to join ancillary studies. Participants who are known by the study team to have ESKD will not have any in-person visits or scheduled telephone calls.

Phase 5 Visit 1

Participants without ESKD will complete one initial visit through the end of 2024 (Visit 1) and one follow up visit during the following year (Visit 2). Data collection has been streamlined in accordance with the Phase 5 objectives . At the in-person visit, informed consent will be obtained for continued participation in the CRIC Study. Blood pressure, weight, and medical history data will be obtained using standardized equipment and protocols established previously in the CRIC Study. Blood and urine samples will be collected for serum creatinine, serum cystatin C, and urine protein/creatinine, the key indicators of kidney outcomes. Serum creatinine will be measured locally using CLIA-approved laboratories, and serum cystatin C and urine protein/creatinine will be measured at the CRIC Central Laboratory (CCL) at the University of Pennsylvania. As has been done in earlier phases, the results of the serum creatinine measurement will be provided to participants. Serum and urine remaining after the centralized measurements will be stored at the CCL during the Phase 5 award period for potential analyses in the future. For participants who are unable to come to the Clinical Center for an in-person visit, informed consent and the medical history and hospitalization data will be obtained by telephone. Participants should be encouraged to get blood drawn at a laboratory or at their home if they are not able to come to the Clinical Center.

Phase 5 Visit 2

The follow-up visit for participants without ESKD can take place by telephone or in person. During the follow-up visit, medical history updates and hospitalization data will be collected.

The subset of participants who participated in any of the three Phase 4 subprotocols will be asked to have a second blood draw for creatinine measurement at or around the time of Visit

2. The creatinine measurement can be performed at the study site, at a commercial laboratory, or at the participant's home.

Follow-up of Participants who have Reached ESKD

Participants who have reached ESKD before the start of Phase 5 will not have in person visits but will be consented via a telephone visit for passive follow-up through linkages with the US Renal Data System, the National Death Index, and other national billing claims or other databases. These participants will also be asked to consent to sharing their contact information with the SDCC to facilitate potential future studies. Sharing of contact information is not required for participation in Phase 5. While participants who have reached ESKD will not undergo in-person visits as part of the core CRIC Phase 5 protocol, they may be invited to complete additional visits/activities for ancillary studies.

Close Out Activities

During the 3 years of the Clinical Center Phase 5 funding period, the Clinical Centers will hold local events to express appreciation to study participants for their contribution over many years and to provide them with an overview of major findings. The last 6 months of the Clinical Center funding period will focus on closeout activities including resolution of data queries, storage of study documents, and regulatory reporting and completion of outcome ascertainment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5499
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	University of Michigan Hospitals	Ann Arbor	Michigan
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland
United States	University of Maryland Medical System	Baltimore	Maryland
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Metrohealth Medical Center	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Wayne State - Harper University Hospital	Detroit	Michigan
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Kaiser Permanente of Northern California	Oakland	California
United States	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	University of California	San Francisco	California

Sponsors (8)

Lead Sponsor	Collaborator
University of Pennsylvania	Case Western Reserve University, Johns Hopkins University, Kaiser Permanente, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tulane University, University of Illinois at Chicago, University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (52)

Adeseun GA, Xie D, Wang X, Joffe MM, Mohler ER 3rd, Townsend RR, Budoff M, Rosas SE. Carotid plaque, carotid intima-media thickness, and coronary calcification equally discriminate prevalent cardiovascular disease in kidney disease. Am J Nephrol. 2012;36( — View Citation

Anderson AH, Yang W, Hsu CY, Joffe MM, Leonard MB, Xie D, Chen J, Greene T, Jaar BG, Kao P, Kusek JW, Landis JR, Lash JP, Townsend RR, Weir MR, Feldman HI; CRIC Study Investigators. Estimating GFR among participants in the Chronic Renal Insufficiency Coho — View Citation

Bansal N, Keane M, Delafontaine P, Dries D, Foster E, Gadegbeku CA, Go AS, Hamm LL, Kusek JW, Ojo AO, Rahman M, Tao K, Wright JT, Xie D, Hsu CY; CRIC Study Investigators. A longitudinal study of left ventricular function and structure from CKD to ESRD: th — View Citation

Budoff MJ, Rader DJ, Reilly MP, Mohler ER 3rd, Lash J, Yang W, Rosen L, Glenn M, Teal V, Feldman HI; CRIC Study Investigators. Relationship of estimated GFR and coronary artery calcification in the CRIC (Chronic Renal Insufficiency Cohort) Study. Am J Kid — View Citation

Chen J, Mohler ER 3rd, Xie D, Shlipak MG, Townsend RR, Appel LJ, Raj DS, Ojo AO, Schreiber MJ, Strauss LF, Zhang X, Wang X, He J, Hamm LL; CRIC Investigators. Risk factors for peripheral arterial disease among patients with chronic kidney disease. Am J Ca — View Citation

DeLoach SS, Appel LJ, Chen J, Joffe MM, Gadegbeku CA, Mohler ER 3rd, Parsa A, Perumal K, Rafey MA, Steigerwalt SP, Teal V, Townsend RR, Rosas SE. Aortic pulse pressure is associated with carotid IMT in chronic kidney disease: report from Chronic Renal Ins — View Citation

Dobre M, Yang W, Chen J, Drawz P, Hamm LL, Horwitz E, Hostetter T, Jaar B, Lora CM, Nessel L, Ojo A, Scialla J, Steigerwalt S, Teal V, Wolf M, Rahman M; CRIC Investigators. Association of serum bicarbonate with risk of renal and cardiovascular outcomes in — View Citation

Faul C, Amaral AP, Oskouei B, Hu MC, Sloan A, Isakova T, Gutierrez OM, Aguillon-Prada R, Lincoln J, Hare JM, Mundel P, Morales A, Scialla J, Fischer M, Soliman EZ, Chen J, Go AS, Rosas SE, Nessel L, Townsend RR, Feldman HI, St John Sutton M, Ojo A, Gadegb — View Citation

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. doi: 10.1097/01.asn.0000070149.78399.ce. — View Citation

Ferguson JF, Matthews GJ, Townsend RR, Raj DS, Kanetsky PA, Budoff M, Fischer MJ, Rosas SE, Kanthety R, Rahman M, Master SR, Qasim A, Li M, Mehta NN, Shen H, Mitchell BD, O'Connell JR, Shuldiner AR, Ho WK, Young R, Rasheed A, Danesh J, He J, Kusek JW, Ojo — View Citation

Fischer MJ, Go AS, Lora CM, Ackerson L, Cohan J, Kusek JW, Mercado A, Ojo A, Ricardo AC, Rosen LK, Tao K, Xie D, Feldman HI, Lash JP; CRIC and H-CRIC Study Groups. CKD in Hispanics: Baseline characteristics from the CRIC (Chronic Renal Insufficiency Cohor — View Citation

Fischer MJ, Xie D, Jordan N, Kop WJ, Krousel-Wood M, Kurella Tamura M, Kusek JW, Ford V, Rosen LK, Strauss L, Teal VL, Yaffe K, Powe NR, Lash JP; CRIC Study Group Investigators. Factors associated with depressive symptoms and use of antidepressant medicat — View Citation

Grunwald JE, Alexander J, Maguire M, Whittock R, Parker C, McWilliams K, Lo JC, Townsend R, Gadegbeku CA, Lash JP, Fink JC, Rahman M, Feldman H, Kusek J, Ojo A; CRIC Study Group. Prevalence of ocular fundus pathology in patients with chronic kidney diseas — View Citation

Grunwald JE, Alexander J, Ying GS, Maguire M, Daniel E, Whittock-Martin R, Parker C, McWilliams K, Lo JC, Go A, Townsend R, Gadegbeku CA, Lash JP, Fink JC, Rahman M, Feldman H, Kusek JW, Xie D, Jaar BG; CRIC Study Group. Retinopathy and chronic kidney dis — View Citation

Grunwald JE, Ying GS, Maguire M, Pistilli M, Daniel E, Alexander J, Whittock-Martin R, Parker C, Mohler E, Lo JC, Townsend R, Gadegbeku CA, Lash JP, Fink JC, Rahman M, Feldman H, Kusek JW, Xie D, Coleman M, Keane MG; Chronic Renal Insufficiency Cohort (CR — View Citation

Gupta J, Mitra N, Kanetsky PA, Devaney J, Wing MR, Reilly M, Shah VO, Balakrishnan VS, Guzman NJ, Girndt M, Periera BG, Feldman HI, Kusek JW, Joffe MM, Raj DS; CRIC Study Investigators. Association between albuminuria, kidney function, and inflammatory bi — View Citation

Gutierrez OM, Anderson C, Isakova T, Scialla J, Negrea L, Anderson AH, Bellovich K, Chen J, Robinson N, Ojo A, Lash J, Feldman HI, Wolf M; CRIC Study Group. Low socioeconomic status associates with higher serum phosphate irrespective of race. J Am Soc Nep — View Citation

He J, Reilly M, Yang W, Chen J, Go AS, Lash JP, Rahman M, DeFilippi C, Gadegbeku C, Kanthety R, Tao K, Hamm LL, Ojo A, Townsend R, Budoff M; CRIC Investigators. Risk factors for coronary artery calcium among patients with chronic kidney disease (from the — View Citation

Hsu CY, Propert K, Xie D, Hamm L, He J, Miller E, Ojo A, Shlipak M, Teal V, Townsend R, Weir M, Wilson J, Feldman H; CRIC Investigators. Measured GFR does not outperform estimated GFR in predicting CKD-related complications. J Am Soc Nephrol. 2011 Oct;22( — View Citation

Isakova T, Anderson CA, Leonard MB, Xie D, Gutierrez OM, Rosen LK, Theurer J, Bellovich K, Steigerwalt SP, Tang I, Anderson AH, Townsend RR, He J, Feldman HI, Wolf M; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Diuretics, calciuria and secondar — View Citation

Isakova T, Wahl P, Vargas GS, Gutierrez OM, Scialla J, Xie H, Appleby D, Nessel L, Bellovich K, Chen J, Hamm L, Gadegbeku C, Horwitz E, Townsend RR, Anderson CA, Lash JP, Hsu CY, Leonard MB, Wolf M. Fibroblast growth factor 23 is elevated before parathyro — View Citation

Isakova T, Xie H, Yang W, Xie D, Anderson AH, Scialla J, Wahl P, Gutierrez OM, Steigerwalt S, He J, Schwartz S, Lo J, Ojo A, Sondheimer J, Hsu CY, Lash J, Leonard M, Kusek JW, Feldman HI, Wolf M; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Fibr — View Citation

Joffe M, Hsu CY, Feldman HI, Weir M, Landis JR, Hamm LL; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Variability of creatinine measurements in clinical laboratories: results from the CRIC study. Am J Nephrol. 2010;31(5):426-34. doi: 10.1159/000 — View Citation

Kurella Tamura M, Xie D, Yaffe K, Cohen DL, Teal V, Kasner SE, Messe SR, Sehgal AR, Kusek J, DeSalvo KB, Cornish-Zirker D, Cohan J, Seliger SL, Chertow GM, Go AS. Vascular risk factors and cognitive impairment in chronic kidney disease: the Chronic Renal — View Citation

Ky B, Shults J, Keane MG, Sutton MS, Wolf M, Feldman HI, Reese PP, Anderson CA, Townsend RR, Deo R, Lo J, Gadegbeku C, Carlow D, Sulik MJ, Leonard MB; CRIC Study Investigators. FGF23 modifies the relationship between vitamin D and cardiac remodeling. Circ — View Citation

Lash JP, Go AS, Appel LJ, He J, Ojo A, Rahman M, Townsend RR, Xie D, Cifelli D, Cohan J, Fink JC, Fischer MJ, Gadegbeku C, Hamm LL, Kusek JW, Landis JR, Narva A, Robinson N, Teal V, Feldman HI; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Chroni — View Citation

Liu KD, Yang W, Anderson AH, Feldman HI, Demirjian S, Hamano T, He J, Lash J, Lustigova E, Rosas SE, Simonson MS, Tao K, Hsu CY; Chronic Renal Insufficiency Cohort (CRIC) study investigators. Urine neutrophil gelatinase-associated lipocalin levels do not — View Citation

Lora CM, Ricardo AC, Brecklin CS, Fischer MJ, Rosman RT, Carmona E, Lopez A, Balaram M, Nessel L, Tao KK, Xie D, Kusek JW, Go AS, Lash JP. Recruitment of Hispanics into an observational study of chronic kidney disease: the Hispanic Chronic Renal Insuffici — View Citation

Margolis DJ, Gupta J, Thom SR, Townsend RR, Kanetsky PA, Hoffstad O, Papdopoulos M, Fischer M, Schelling JR, Mitra N. Diabetes, lower extremity amputation, loss of protective sensation, and neuronal nitric oxide synthase associated protein in the chronic — View Citation

Mishra RK, Li Y, DeFilippi C, Fischer MJ, Yang W, Keane M, Chen J, He J, Kallem R, Horwitz EJ, Rafey M, Raj DS, Go AS, Shlipak MG; CRIC Study Investigators. Association of cardiac troponin T with left ventricular structure and function in CKD. Am J Kidney — View Citation

Mishra RK, Li Y, Ricardo AC, Yang W, Keane M, Cuevas M, Christenson R, deFilippi C, Chen J, He J, Kallem RR, Raj DS, Schelling JR, Wright J, Go AS, Shlipak MG; Chronic Renal Insufficiency Cohort Investigators. Association of N-terminal pro-B-type natriure — View Citation

Munoz Mendoza J, Isakova T, Ricardo AC, Xie H, Navaneethan SD, Anderson AH, Bazzano LA, Xie D, Kretzler M, Nessel L, Hamm LL, Negrea L, Leonard MB, Raj D, Wolf M; Chronic Renal Insufficiency Cohort. Fibroblast growth factor 23 and Inflammation in CKD. Cli — View Citation

Muntner P, Anderson A, Charleston J, Chen Z, Ford V, Makos G, O'Connor A, Perumal K, Rahman M, Steigerwalt S, Teal V, Townsend R, Weir M, Wright JT Jr; Chronic Renal Insufficiency Cohort (CRIC) Study Investigators. Hypertension awareness, treatment, and c — View Citation

Park M, Hsu CY, Li Y, Mishra RK, Keane M, Rosas SE, Dries D, Xie D, Chen J, He J, Anderson A, Go AS, Shlipak MG; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Associations between kidney function and subclinical cardiac abnormalities in CKD. J Am — View Citation

Ricardo AC, Hacker E, Lora CM, Ackerson L, DeSalvo KB, Go A, Kusek JW, Nessel L, Ojo A, Townsend RR, Xie D, Ferrans CE, Lash JP; CRIC Investigators. Validation of the Kidney Disease Quality of Life Short Form 36 (KDQOL-36) US Spanish and English versions — View Citation

Ricardo AC, Lash JP, Fischer MJ, Lora CM, Budoff M, Keane MG, Kusek JW, Martinez M, Nessel L, Stamos T, Ojo A, Rahman M, Soliman EZ, Yang W, Feldman HI, Go AS; CRIC and HCRIC Investigators. Cardiovascular disease among hispanics and non-hispanics in the c — View Citation

Scialla JJ, Appel LJ, Wolf M, Yang W, Zhang X, Sozio SM, Miller ER 3rd, Bazzano LA, Cuevas M, Glenn MJ, Lustigova E, Kallem RR, Porter AC, Townsend RR, Weir MR, Anderson CA; Chronic Renal Insufficiency Cohort-CRIC Study Group. Plant protein intake is asso — View Citation

Scialla JJ, Lau WL, Reilly MP, Isakova T, Yang HY, Crouthamel MH, Chavkin NW, Rahman M, Wahl P, Amaral AP, Hamano T, Master SR, Nessel L, Chai B, Xie D, Kallem RR, Chen J, Lash JP, Kusek JW, Budoff MJ, Giachelli CM, Wolf M; Chronic Renal Insufficiency Coh — View Citation

Scialla JJ, Leonard MB, Townsend RR, Appel L, Wolf M, Budoff MJ, Chen J, Lustigova E, Gadegbeku CA, Glenn M, Hanish A, Raj D, Rosas SE, Seliger SL, Weir MR, Parekh RS; CRIC Study Group. Correlates of osteoprotegerin and association with aortic pulse wave — View Citation

Shlipak MG, Lash JP, Yang W, Teal V, Keane M, Cappola T, Keller C, Jamerson K, Kusek J, Delafontaine P, He J, Miller ER 3rd, Schreiber M, Go AS; CRIC Investigators. Symptoms characteristic of heart failure among CKD patients without diagnosed heart failur — View Citation

Soliman EZ, Prineas RJ, Go AS, Xie D, Lash JP, Rahman M, Ojo A, Teal VL, Jensvold NG, Robinson NL, Dries DL, Bazzano L, Mohler ER, Wright JT, Feldman HI; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Chronic kidney disease and prevalent atrial fi — View Citation

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. doi: 10.1681/ASN.2007020199. Epub 2007 Sep 12. — View Citation

Townsend RR, Anderson AH, Chen J, Gadebegku CA, Feldman HI, Fink JC, Go AS, Joffe M, Nessel LA, Ojo A, Rader DJ, Reilly MP, Teal V, Teff K, Wright JT, Xie D. Metabolic syndrome, components, and cardiovascular disease prevalence in chronic kidney disease: — View Citation

Townsend RR, Chirinos JA, Parsa A, Weir MA, Sozio SM, Lash JP, Chen J, Steigerwalt SP, Go AS, Hsu CY, Rafey M, Wright JT Jr, Duckworth MJ, Gadegbeku CA, Joffe MP; Chronic Renal Insufficiency Cohort Investigators. Central pulse pressure in chronic kidney d — View Citation

Townsend RR, Wimmer NJ, Chirinos JA, Parsa A, Weir M, Perumal K, Lash JP, Chen J, Steigerwalt SP, Flack J, Go AS, Rafey M, Rahman M, Sheridan A, Gadegbeku CA, Robinson NA, Joffe M. Aortic PWV in chronic kidney disease: a CRIC ancillary study. Am J Hyperte — View Citation

Wahl P, Xie H, Scialla J, Anderson CA, Bellovich K, Brecklin C, Chen J, Feldman H, Gutierrez OM, Lash J, Leonard MB, Negrea L, Rosas SE, Anderson AH, Townsend RR, Wolf M, Isakova T; Chronic Renal Insufficiency Cohort Study Group. Earlier onset and greater — View Citation

Weir MR, Townsend RR, Fink JC, Teal V, Anderson C, Appel L, Chen J, He J, Litbarg N, Ojo A, Rahman M, Rosen L, Sozio SM, Steigerwalt S, Strauss L, Joffe MM. Hemodynamic correlates of proteinuria in chronic kidney disease. Clin J Am Soc Nephrol. 2011 Oct;6 — View Citation

Weir MR, Townsend RR, Fink JC, Teal V, Sozio SM, Anderson CA, Appel LJ, Turban S, Chen J, He J, Litbarg N, Ojo A, Rahman M, Rosen L, Steigerwalt S, Strauss L, Joffe MM. Urinary sodium is a potent correlate of proteinuria: lessons from the chronic renal in — View Citation

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. — View Citation

Xie D, Joffe MM, Brunelli SM, Beck G, Chertow GM, Fink JC, Greene T, Hsu CY, Kusek JW, Landis R, Lash J, Levey AS, O'Conner A, Ojo A, Rahman M, Townsend RR, Wang H, Feldman HI. A comparison of change in measured and estimated glomerular filtration rate in — View Citation

Yaffe K, Ackerson L, Hoang TD, Go AS, Maguire MG, Ying GS, Daniel E, Bazzano LA, Coleman M, Cohen DL, Kusek JW, Ojo A, Seliger S, Xie D, Grunwald JE; CRIC Study Investigators. Retinopathy and cognitive impairment in adults with CKD. Am J Kidney Dis. 2013 — View Citation

Yaffe K, Ackerson L, Kurella Tamura M, Le Blanc P, Kusek JW, Sehgal AR, Cohen D, Anderson C, Appel L, Desalvo K, Ojo A, Seliger S, Robinson N, Makos G, Go AS; Chronic Renal Insufficiency Cohort Investigators. Chronic kidney disease and cognitive function — View Citation

* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   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.