Chronic kidney disease (CKD) and its metabolic derangements substantially affect the well-being of children.In order to define the nature, magnitude, and temporal evolution of the adverse effects of progressive CKD,we propose to extend the follow-up of the Prospective Study of the Chronic Kidney Disease in Children(CKiD) to determine (1) risk factors for accelerated decline; (2) factors contributing to abnormalities of growthand associated morbidity; (3) prevalence of risk factors for cardiovascular disease; and (4) impact onneurocognitive abilities, social-behavioral functioning and quality of life. The CKiD is a cooperative effort of aData Coordinating Center, a Central Biochemistry Lab and two Clinical Coordinating Centers (CCC's) thatoversee subject recruitment and retention at 44 participating clinical sites in the US and Canada. Since studyinitiation in Oct 2003, we finalized and implemented a common protocol at 44 sites, met our recruitment goalof 540 children, aged 1 to <= 16 yrs with estimated glomerular filtration rate (GFR) 30-90 ml/min/1.73m2formula and have successfully retained the cohort to date. At enrollment, 6 month and annual visitsthereafter, selected exposures are obtained on participants, including sociodemographic characteristics,family history, healthcare utilization, environmental exposures and medication use using standardizedquestionnaires. Standardized blood pressure, growth and nutritional assessments, metabolic status,measures of anemia, dyslipidemia, microinflammation, and proteinuria are also measured. Level of kidneyfunction (GFR) is measured annually for 2 years then every other year by plasma disappearance of iohexol.The primary outcomes of interest is the temporal evolution of subclinical measures and clinical eventsassociated with CKD progression as measured by decline in GFR, growth failure and its treatment,neurocognitive and behavioral deficits and cardiovascular disease, specified in our aims. Potential analysesthat will be conducted using the CKiD infrastructure to explore risk-factor disease relationships includetraditional prospective cohort analyses where putative risk factors are measured in participants at baseline;nested case-control studies in which laboratory studies are performed on stored baseline specimens incases (e.g.rapid progressors) and appropriately matched controls (e.g.non-progressors); and cross-cohortanalyses utilizing parallel cohorts.PERFORMANCE SITE(S) (organization, city, state)Johns Hopkins Medical Institutions, Baltimore, MDMontefiore Medical Center, Bronx, NYWayne State University, Detroit, Ml Children's Memorial Hospital, Chicago, ILMt. Sinai Medical School, New York, NY Weill Medical College, Cornell University, New York, NYINOVA Fairfax Hospital for Children, Fairfax, VA University of Maryland Hospital, Baltimore, MDUniversity of Rochester School of Medicine and Dentistry, Rochester, NYRiley Hospital for Children, Indiana University, Indianapolis, IAUniversity of Virginia Children's Medical Center, Charlottesville, VAUniversity of New Jersey, New Brunswick, NY University of Michigan, Ann Arbor, MlUniversity of Florida, Gainesville, FL UNC Kidney Center, Chapel Hill, NCSpectrum Health Hospitals, Grand Rapids, Ml Carolinas Medical Center, Charlotte, NCHealth Science Center at the University of Texas, Houston, TXMaria Fareri Children's Hospital, Valhalla, NYSUNY Downstate Medical CenterUniversity of Illinois at ChicagoPHS 398 (Rev. 04/06) Page 2 Form Page 2 Principal Investigator/Program Director (Last, First, Middle): Fufth, SUSSH LKEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below.Start with Principal Investigator(s). List all other key personnel in alphabetical order, last name first.Name eRA Commons User Name Organization Role on ProjectFurth, Susan MD PhD Johns Hopkins Principal InvestigatorKaskel, Frederick MD Montefiore Medical Ctr Co-PiFivush, Barbara Johns Hopkins Co-InvestigatorGerson, Arlene Johns Hopkins Co-InvestigatorOTHER SIGNIFICANT CONTRIBUTORSName Organization Role on ProjectHuman Embryonic Stem Cells D No Q YesIf the proposed project involves human embryonic stem cells, list below the registration number of the specific cell llne(s) from the following list:http://Stemcells.nih.gov/reqistry/index.asP. Usecontinuation pages as needed.If a specific line cannot be referenced at this time, include a statement that one from the Registry will be used.Cell LinePHS 398 (Rev. 04/06) Page 3 Form Page 2-continuedNumber the following pages consecutively throughoutthe application. Do not use suffixes such as 4a, 4b.Principal Investigator/Program Director (Last, First, Middle): Furth, Susan L.LIST OFPi'sDr. Tej MattooWayne State UniversityChildren's Hospital of Michigan3901 Beaubien BlvdDetroit, Ml 48201Dr. Craig LangmanChildren's Memorial HospitalNorthwestern University2300 Children's Plaza, Box #37Chicago, IL 60614Dr. Kanwal KherChildren's National Medical CenterChildren's Hospital111 Michigan Avenue, NWWashington, DC 20010Dr. Mark MentserColumbus Children's HospitalOhio State University700 Children's Drive, ED 646Columbus, OH 43205-2666Dr. Lynn YaoINOVA Fairfax Hospital for Children8505 Arlington Blvd. Suite 100Fairfax, VA 22031Dr. Sharon AndreoliRiley Hospital for ChildrenIndiana University699 West DriveIndianapolis, IA 46303Dr. Susan MendleyUniversity of Maryland HospitalN5W6722 S. Greene StreetBaltimore, MD21201Dr. Katherine CollinsUniversity of Michigan, Mott HospitalMott F6865 - Box 02971505 Simpson RoadAnn Arbor, Ml 48109-0297Dr. Debbie S. GipsonUNC Kidney Center7012 Burnett-Womack Bldg.CB#7155Chapel Hill, NC 27599-7155PHS 398/2590 (Rev. 09/04, Reissued 4/2006)Dr. Frederick KaskelMontefiore Medical Center111 East 210th St.Bronx, NY 10467Dr. Jeffrey SalandMt. Sinai Medical SchoolOne Gustave L. Levy PlaceBox1075New York, NY 10029-6574Dr. Marc LandeDepartment of PediatricsUniversity of Rochester School of Medicine andDentistry601 Elmwood Avenue (Box 777)Rochester, NY 14642-8777Dr. Victoria NorwoodUniv. of Virginia Children's Med CtrPO Box 800903Charlottesville, VA 22908Dr. Hilary HotchkissUniversity of New Jersey (UMDNJ)Robert Wood Johnson Medical Center1 Robert W Johnson PI CN 19New Brunswick, NJ 08903-0019Dr. Vikas DharnidhaUniversity of FloridaPO Box 100296, Room HD-2141600 SW Archer RoadGainesville, FL 32610-0296Dr. Gina BarlettaSpectrum Health Hospitals _DVCH100 Michigan NE, MC 38Grand Rapids, Ml 49503Dr. Susan MassengillCarolinas Medical Center1000 Blythe Blvd.P. O. Box 32861Charlotte, NC 28232Dr. Anil MongiaDepartment of PediatricsSUNY Downstate Medical Center445 Lenox Road, Box 49Brooklyn, NY 11203-2098Page -4 Continuation Format PagePrincipal Investigator/Program Director (Last, First, Middle): Furth, Susan L.Dr. Joshua SamuelsHealth Science Center at the University ofTexas6431 Fannin St.,MSB3.124Houston, TX 77030Dr. Robert WeissMaria Fareri Children's HospitalWeschester Medical CenterMunger Pavilion, Room 116Valhalla, NY 10595PHS 398/2590 (Rev. 09/04, Reissued 4/2006}Dr. Guillermo HidalgoDivision of Pediatric NephrologyUniversity of Illinois Medical Center at Chicago840 South Wood Street (MIC856)Chicago, IL 60612Page ET Continuation Format Page Principal Investigator/Program Director (Last, First, Middle): Furth, Susan L.The name of the principal investigator/program director must be provided at the top of each printed page and each continuation page. RESEARCH GRANT TABLE OF CONTENTS Page NumbersFace Page 1Description, Performance Sites, Key Personnel, Other Significant Contributors, and HumanEmbryonic Stem CellsTable of ContentsDetailed Budget for Initial Budget Period (or Modular Budget)Budget for Entire Proposed Period of Support (not applicable with Modular Budget)Budgets Pertaining to Consortium/Contractual Arrangements (not applicable with Modular Budget) 12Biographical Sketch - Principal Investigator/ProgramDirector (Not to exceed four pages) 92Other Biographical Sketches (Not to exceed four pages for each - Seeinstructions) 96Resources 106Research Plan. 108Introduction to Revised/Resubmission Application (Not to exceed 3 pages.)..Introduction to Supplemental/Revision Application (Not to exceed one page.). A.
Specific Aims 1 08 B. Background and Significance 109 C. Preliminary Studies/Progress Report (Items A-D: not to exceed 25 pages). 115 D. Research Design and Methods 125 E. Human Subjects Research 133 Protection of Human Subjects (Required if Item 4 on the Face Page is marked 'Yes') 142 Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked 'Yes' and a Phase I, II, or III clinical trial is proposed) Inclusion of Women and Minorities (Required if Item 4 on the Face Page is marked 'Yes' and is Clinical Research). 142 Targeted/Planned Enrollment Table (for new and continuing clinical research studies) 144 Inclusion of Children (Required if Item 4 on the Face Page is marked 'Yes') 143 F. Vertebrate Animals 145 G. Select Agent Research 145 H. Literature Cited 153 I. Multiple PI Leadership Plan 153 J. Consortium/Contractual Arrangements 153 K. Resource Sharing 153 L. Letters of Support (e.g., Consultants) 153Checklist 154 Check ifAppendix (Five collated sets. Nopage numbering necessary for Appendix.) Appendix is IncludedNumber of publications and manuscripts accepted for publication (not to exceed 10) Other items (list):PHS 398 (Rev. 04/06) Page_g Form Page 3
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