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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00304148
Recruitment Status : Active, not recruiting
First Posted : March 17, 2006
Last Update Posted : August 26, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date March 14, 2006
First Posted Date March 17, 2006
Last Update Posted Date August 26, 2020
Study Start Date July 2003
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2007)
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 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: December 17, 2007)
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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SDCC - Prospective Cohort Study of Chronic Renal Insufficiency
Official Title Prospective Cohort Study of Chronic Renal Insufficiency
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.

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:

  • weight is measured
  • 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)
  • urine sample collection for kidney function testing
  • 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA, urine, serum, blood
Sampling Method Probability Sample
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.
Condition Renal Insufficiency, Chronic
Intervention Not Provided
Study Groups/Cohorts
  • CRIC Cohort
  • CRIC Subcohort
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 1, 2013)
5112
Original Enrollment
 (submitted: March 16, 2006)
3300
Estimated Study Completion Date June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00304148
Other Study ID Numbers DK60990
U01DK060990 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators
  • 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
PRS Account University of Pennsylvania
Verification Date August 2020