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CASIRE Sickle Cell Renal Disease Cohort International Study Protocol
Clinical Trial ( IRB ) #: 13-061C-6.2
Title: CASIRE Sickle Cell Renal Disease Cohort International Study Protocol
Principal Investigator: Dr. Biree Andemariam
Description: Study design: This study's design is cross-sectional. Our cross-sectional study approach will allow us to determine particular age cohorts (young children, adolescents and young adults) that might be at risk for developing early renal dysfunction. Further, it will also allow us to determine which estimates of GFR have the best correlation to the changes in renal function. Specifically, we will determine if estimates in GFR, increasing microalbuminuria, or blood pressure changes will be predictive of early renal dysfunction. Study procedures: The research staff, which includes study coordinators from UCHC and CCMC, co-investigators from CCMC, and a principal investigator from UCHC, will only enroll subjects with sickle cell disease who are at steady state and have not had an infection, pain crisis, emergency room visit or hospitalization within two weeks of the time that they are enrolled in the study. Subjects will be screened by the PI or co-investigators, with whom they have a treating relationship. Potential subjects will be told about the study by the PI or co-investigators during a routine clinical visit. Those potential subjects who verbalize interest in learning more about the study will then have an opportunity to discuss the study further with a member of the research staff. If the subject then verbalizes desire to participate, informed consent will be obtained. The questionnaire will then be administered in its entirety by a member of the research staff by verbally asking the subject to answer each question. If there is any uncertainty about the answer to a particular question, the medical chart will be reviewed for verification. We estimate it will take about 20-30 minutes for the subjects to fill out the questionnaire with a research staff member. The subject's involvement ends once the questionnaire is completed.
  Blood - Sickle Cell Disease
  Kidney, Bladder, Prostate and Urinary
Eligibility Criteria: Check with study contact
How to Contact: Ektor Rafti. Telephone: 860-679-7021. Email: ERafti@uchc.edu or Sasia-Marie Jones. Telephone: Not available. Email: sajones@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.