Renal Insufficiency, ChronicCRICNCT00304148
SDCC - Prospective Cohort Study of Chronic Renal Insufficiency
An observational study of Renal Insufficiency, Chronic, run by University of Pennsylvania at 12 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- How many people
- 5,499 participants
- Where
- 12 sitesUnited States
- Study dates
- Jul 2003to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In Phase I of the CRIC Study a total of 3,939 individuals across the spectrum of severity of kidney disease were enrolled to ensure that a sufficient number of patients reach the primary study endpoints of kidney disease progression and cardiovascular events. During CRIC Phase III, an additional 1,560 older participants with milder severity of kidney disease were recruited. The 1,560 new cohort members, compared with participants recruited in Phase I, have higher ranges of age and more preserved kidney function, and most have proteinuria. The population of 1560 new recruits have similar characteristics as the current CRIC cohort: ~50% with Diabetes, ~50% female, ~45% white and ~45% African-American.
Who may be able to join
- During the screening visit a blood sample will be tested to indirectly check kidney function based on the serum creatinine level:
- Age Range: 21 - 79 years
- Estimated Glomerular Filtration Rate (GFR): 45 - 70 mL/min/1.73m²
- Proteinuria: varies dependent on eGRF
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Michigan Hospitals
Ann Arbor, Michigan, 48106
University of Maryland Medical System
Baltimore, Maryland, 21201
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21205
University of Illinois at Chicago
Chicago, Illinois, 60612
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Metrohealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Wayne State - Harper University Hospital
Detroit, Michigan, 48201
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Kaiser Permanente of Northern California
Oakland, California, 94612
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
University of California
San Francisco, California, 94143-0532
About this study
Official title: Prospective Cohort Study of Chronic Renal Insufficiency
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.
Read the detailed 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.
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Renal Insufficiency Chronic
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRIC Cohort | Not described | |
| CRIC Subcohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 yrs
Secondary outcomes (1)
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.
Measured: 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startJul 2003
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,499 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Johns Hopkins University, Case Western Reserve University, University of Michigan, University of Illinois Chicago, Tulane University, Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Laura Dember, M.D., Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304148
- Sponsor's protocol ID
- DK60990
- Other IDs
- U01DK060990
- Acronym
- CRIC
- Status last verified
- Oct 2026
- First submitted
- 14 Mar 2006
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1097/01.asn.0000070149.78399.ce.
PubMed 12819321Wimmer 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.
PubMed 17915615Stevens 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.
PubMed 17855641Xie 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 patients with nondiabetic kidney disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1332-8. doi: 10.2215/CJN.05631207. Epub 2008 Jul 30.
PubMed 18667734Lash 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. Chronic Renal Insufficiency Cohort (CRIC) Study: baseline characteristics and associations with kidney function. Clin J Am Soc Nephrol. 2009 Aug;4(8):1302-11. doi: 10.2215/CJN.00070109. Epub 2009 Jun 18.
PubMed 19541818DeLoach 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 Insufficiency Cohort. Am J Hypertens. 2009 Dec;22(12):1235-41. doi: 10.1038/ajh.2009.156. Epub 2009 Sep 24.
PubMed 19779470Muntner 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 control in adults with CKD: results from the Chronic Renal Insufficiency Cohort (CRIC) Study. Am J Kidney Dis. 2010 Mar;55(3):441-51. doi: 10.1053/j.ajkd.2009.09.014. Epub 2009 Dec 5.
PubMed 19962808Joffe 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: 10.1159/000296250. Epub 2010 Apr 14.
PubMed 20389058Yaffe 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 in older adults: findings from the chronic renal insufficiency cohort cognitive study. J Am Geriatr Soc. 2010 Feb;58(2):338-45. doi: 10.1111/j.1532-5415.2009.02670.x. Epub 2010 Jan 26.
PubMed 20374407Townsend 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 Hypertens. 2010 Mar;23(3):282-9. doi: 10.1038/ajh.2009.240. Epub 2009 Dec 17.
PubMed 20019670Gutierrez 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 Nephrol. 2010 Nov;21(11):1953-60. doi: 10.1681/ASN.2010020221. Epub 2010 Sep 16.
PubMed 20847142Grunwald 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 disease. Clin J Am Soc Nephrol. 2010 May;5(5):867-73. doi: 10.2215/CJN.08271109. Epub 2010 Mar 18.
PubMed 20299372Soliman 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 fibrillation: the Chronic Renal Insufficiency Cohort (CRIC). Am Heart J. 2010 Jun;159(6):1102-7. doi: 10.1016/j.ahj.2010.03.027.
PubMed 20569726Townsend 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 disease: a chronic renal insufficiency cohort ancillary study. Hypertension. 2010 Sep;56(3):518-24. doi: 10.1161/HYPERTENSIONAHA.110.153924. Epub 2010 Jul 26.
PubMed 20660819Townsend 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: findings from the Chronic Renal Insufficiency Cohort (CRIC) Study. Am J Nephrol. 2011;33(6):477-84. doi: 10.1159/000327618. Epub 2011 Apr 27.
PubMed 21525746
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Chronic Renal Insufficiency
- ClinicalTrials.gov ID
- NCT00304148
- Acronym / sponsor ID
- CRIC / DK60990
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Renal Insufficiency Chronic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,499 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Johns Hopkins University, Case Western Reserve University, University of Michigan, University of Illinois Chicago, Tulane University, Kaiser Permanente
- Study start
- Jul 2003 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRIC Cohort | – | – |
| CRIC Subcohort | – | – |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In Phase I of the CRIC Study a total of 3,939 individuals across the spectrum of severity of kidney disease were enrolled to ensure that a sufficient number of patients reach the primary study endpoints of kidney disease progression and cardiovascular events. During CRIC Phase III, an additional 1,560 older participants with milder severity of kidney disease were recruited. The 1,560 new cohort members, compared with participants recruited in Phase I, have higher ranges of age and more preserved kidney function, and most have proteinuria. The population of 1560 new recruits have similar characteristics as the current CRIC cohort: ~50% with Diabetes, ~50% female, ~45% white and ~45% African-American.
Key inclusion criteria (4 listed)
- During the screening visit a blood sample will be tested to indirectly check kidney function based on the serum creatinine level:
- Age Range: 21 - 79 years
- Estimated Glomerular Filtration Rate (GFR): 45 - 70 mL/min/1.73m²
- Proteinuria: varies dependent on eGRF
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 5 yrs
1 secondary outcome
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.
Time frame: 5 yrs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Background: PubMed 12819321Feldman 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.
- Background: PubMed 17915615Wimmer 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.
- Background: PubMed 17855641Stevens 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.
- Results publication: PubMed 18667734Xie 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 patients with nondiabetic kidney disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1332-8. doi: 10.2215/CJN.05631207. Epub 2008 Jul 30.
- Results publication: PubMed 19541818Lash 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. Chronic Renal Insufficiency Cohort (CRIC) Study: baseline characteristics and associations with kidney function. Clin J Am Soc Nephrol. 2009 Aug;4(8):1302-11. doi: 10.2215/CJN.00070109. Epub 2009 Jun 18.
- Results publication: PubMed 19779470DeLoach 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 Insufficiency Cohort. Am J Hypertens. 2009 Dec;22(12):1235-41. doi: 10.1038/ajh.2009.156. Epub 2009 Sep 24.
- Results publication: PubMed 19962808Muntner 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 control in adults with CKD: results from the Chronic Renal Insufficiency Cohort (CRIC) Study. Am J Kidney Dis. 2010 Mar;55(3):441-51. doi: 10.1053/j.ajkd.2009.09.014. Epub 2009 Dec 5.
- Results publication: PubMed 20389058Joffe 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: 10.1159/000296250. Epub 2010 Apr 14.
- Results publication: PubMed 20374407Yaffe 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 in older adults: findings from the chronic renal insufficiency cohort cognitive study. J Am Geriatr Soc. 2010 Feb;58(2):338-45. doi: 10.1111/j.1532-5415.2009.02670.x. Epub 2010 Jan 26.
- Results publication: PubMed 20019670Townsend 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 Hypertens. 2010 Mar;23(3):282-9. doi: 10.1038/ajh.2009.240. Epub 2009 Dec 17.
- Results publication: PubMed 20847142Gutierrez 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 Nephrol. 2010 Nov;21(11):1953-60. doi: 10.1681/ASN.2010020221. Epub 2010 Sep 16.
- Results publication: PubMed 20299372Grunwald 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 disease. Clin J Am Soc Nephrol. 2010 May;5(5):867-73. doi: 10.2215/CJN.08271109. Epub 2010 Mar 18.
- 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.Link provided by the sponsor.
Related trials for Renal Insufficiency, Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Dember, M.D. study director
University of Pennsylvania
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, Chronic, run by University of Pennsylvania at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 5 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00304148, which also lists 58 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.