SDCC - Prospective Cohort Study of Chronic Renal Insufficiency (CRIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Pennsylvania
Sponsor:
Collaborators:
Johns Hopkins University
Case Western Reserve University
University of Michigan
University of Illinois at Chicago
Tulane University
Kaiser Permanente
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00304148
First received: March 14, 2006
Last updated: February 20, 2014
Last verified: July 2013
  Purpose

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, 3612 participants have been enrolled in the CRIC cohort. The goal for Phase III is to enroll 1500 new participants across all seven Clinical centers (214 new participants per center). Participants previously enrolled will be followed for an additional 5 years and newly recruited participants will be followed for up to an additional 5 years. Principles underlying the targeted composition of the cohort of new recruits are very similar as the Phase I recruits, however with some modifications as listed below in the eligibility summary.

No study treatments or interventions will be given to participants in CRIC. Subjects will include a racially and ethnically diverse group of adults aged 45 to 79 years old with a broad spectrum of renal disease severity and proteinuria levels. Participants who are 65 years or older will undergo additional testing to assess physical and cognitive function, social support, and quality of life.


Condition
Renal Insufficiency, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study of Chronic Renal Insufficiency

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

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 [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

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. [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA, urine, serum, blood


Estimated Enrollment: 5112
Study Start Date: July 2003
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
CRIC Cohort
CRIC Subcohort

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The CRIC Study population will include a racially and ethnically diverse group of adult patients with mild-to-moderate CRI. The 1,500 new cohort members will be recruited into the study, compared with participants recruited in Phase I, these individuals will have higher ranges of age and more preserved kidney function, and most will have proteinuria. The population of 1500 new recruits will have similar characteristics as the current CRIC cohort: ~50% with Diabetes, ~50% female, ~45% white and ~45% African-American.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304148

Contacts
Contact: Sally Thompson, BA 215-573-8926 SallyJ@upenn.edu
Contact: Nancy Robinson-Garvin, PhD 215-573-4421 narobins@upenn.edu

Locations
United States, California
Kaiser Permanente of Northern California Recruiting
Oakland, California, United States, 94612
Contact: Nancy G. Jensvold, M.P.H.    510-891-3553    nancy.jensvold@kp.org   
Principal Investigator: Alan S. Go, M.D.         
University of California Completed
San Francisco, California, United States, 94143-0532
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Janet Cohan, M.S.N.    312-996-6033    jcohan@uic.edu   
Principal Investigator: James P. Lash, M.D.         
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Eva Lustigova, MPH    504-988-4331    elustigo@tulane.edu   
Principal Investigator: Jiang He, M.D., Ph.D         
United States, Maryland
Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21205
Contact: Jeanne Charleston    410-281-1600 ext 1138    jeannec@jhmi.edu   
Contact    410-281-6496      
Principal Investigator: Lawrence J. Appel, M.D., M.P.H.         
University of Maryland Medical System Recruiting
Baltimore, Maryland, United States, 21201
Contact: Wanda Fink, B.S.N.    410-706-6559    wfink@medicine.umaryland.edu   
Sub-Investigator: Jeffrey C. Fink, M.D.         
United States, Michigan
University of Michigan Hospitals Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Denise Cornish-Zirker, B.S.N.    734-998-7947    cricstudy@med.umich.edu   
Principal Investigator: Akinlolu O. Ojo, M.D., PH.D.         
St. John Hospital and Medical Center/RRRI Recruiting
Detroit, Michigan, United States, 48236
Contact: Jennifer DeLuca    313-886-8787 ext 1243    cricdetroit@scsp.net   
Principal Investigator: Susan P. Steigerwalt, M.D.         
Wayne State - Harper University Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Yanni Zhuang, BSN    313-966-9338    aj1344@wayne.edu   
Sub-Investigator: John Flack, M.D.         
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Louise Strauss, RN, BSN    216-844-1285    louise.strauss@uhhospitals.org   
Principal Investigator: Mahboob Rahman, M.D.         
Metrohealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Anne Slaven, MSSA    216-778-1849    aslaven@metrohealth.org   
Principal Investigator: Jeffrey Schelling, M.D.         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Martha Coleman, RN BSN    216-444-3563    colemam@ccf.org   
Sub-Investigator: Martin J. Schreiber, M.D.         
United States, Pennsylvania
University of Pennsylvania Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Wanda Seamon, BS    866-589-2742    wanda.seamon@uphs.upenn.edu   
Principal Investigator: Raymond R. Townsend, M.D.         
Sponsors and Collaborators
University of Pennsylvania
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
  More Information

Additional Information:
Publications:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00304148     History of Changes
Other Study ID Numbers: DK60990, U01DK060990
Study First Received: March 14, 2006
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pennsylvania:
Renal Insufficiency Chronic

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014