The Kidney Subcommittee convened to discuss kidney disease research and other issues related to kidney disease that are of interest to various Federal Agencies. One of those issues was a major development in kidney disease research-the decision by the Surgeon General to accept a chapter on Chronic Kidney Disease for inclusion in the HHS initiative on Healthy People 2010. Dr. Lawrence Agodoa informed attendees that a draft chapter on chronic kidney diseases was developed, and that comments on the draft may be submitted through the end of April, after which no further changes can be made. The lead agencies for the chapter are NIH, HRSA, HCFA, IHS, and the Centers for Disease Control and Prevention (CDC).
Dr. Agodoa welcomed new committee members Drs. D.W. Chen and Laura Saint Martin, both from the Division of Transplantation (DOT) at HRSA. Dr. Chen reported DOT's three major program responsibilities: (1) providing administrative oversight and funding support for the Organ Procurement and Transplantation Network (OPTN), (2) providing administrative oversight and funding support for the National Bone Marrow Registry Program, and (3) coordinating national activities related to organ and tissue donation and increasing awareness and education about these activities.
Dr. Chen reported that in April 1998, HRSA issued a final rule governing operations of the OPTN, which included performance measures that HRSA expects of the transplant community for organ allocation. The issue of fair and equitable allocation sparked much national debate, reached the Office of the Secretary (of the Department of Health and Human Services), and resulted in Congress stepping in October 1998 with a moratorium on HRSA's final regulation. Congress then asked the Institute of Medicine to do a study on this issue. Also under way at UNOS and OPTN was the UNOS Kidney Allocation Model initiative, which involved looking at varying allocation schemes and how they affect outcomes and performance measures. Dr. Chen also announced that HRSA posted a Federal Register announcement in early April proposing a peer reviewed, competitively awarded extramural support program for fiscal year 1999 to fund projects to increase organ and tissue donation.
The Committee also discussed the proposed rule in the Federal Register regarding Medicare coverage for diabetes self-management training services. The kidney complication that is cited to benefit from tight glycemic control is macroalbuminuria, whereas the available data indicates that tight glycemic control is beneficial for microalbuminuric patients (not patients with overt proteinuria). Dr. T.G. Patel said that the National Diabetes Education Program, primarily led by CDC, already has proposed to change the language to microalbuminuria. Dr. Paul Eggers from HCFA said that he would identify the proper channels through which Federal agencies could make comments.
Dr. Patel reported on two VA initiatives¾a study on subcutaneous use of erythropoietin and an unpublished study on the correlation of dialysis dose with morbidity and mortality. Dr. Patel reported he also was working on developing an initiative to educate nephrologists on preparing pre-end-stage-renal-disease (ESRD) patients' forearms for an arteriovenous fistula and how to get a good outcome.
Dr. Stephen Rose reported that the NIAID released a Request for Applications (RFA) on the immunobiology of graft rejection in 1994. Graft survival at one year had improved to approximately 90-95 percent, yet even with new immunosuppressive agents, long-term survival had not changed. He also reported that available data show that the process of chronic graft rejection is immunologically distinct from acute graft rejection; therefore, another RFA would be released in 2001 on the immunopathogenesis of chronic graft rejection. This project will be funded with $2.1 million from NIAID and a matching $2.1 million from NHLBI over five years.
Dr. Winnie Barouch reported that NHLBI had a small program on renal grants. In late January 1999, NHLBI held a workshop on dietary salt and blood pressure. The impetus for the workshop came from clinicians' objections to recommendations to reduce table salt intake. The purpose of the workshop was to look again at the data and the pros and cons of retaining the recommendation. The workshop participants concluded that there is not enough evidence to change the recommendation nor was there enough evidence that harm is done by lowering sodium intake to 2,400 milligrams daily. The participants in the workshop said there is a need for a large randomized clinical trial, but that such a trial would be expensive and difficult to carry out. They suggested, instead, doing a cohort study. Dr. Barouch said that because there is no easy way to determine salt sensitivity, they couldn't make a recommendation that is contingent on salt sensitivity. The report of the workshop is going to the National High Blood Pressure Education Program committee, and NHLBI is not doing any further work in this area at this time. Dr. Barouch also reported that NHLBI would be releasing an RFA for basic research on various vascular organs in the future.There was a report on several kidney disease research activities at the NIDDK:
- Dr. Agodoa reported that the United States Renal Data System 1999 annual report was available in print and on CD-ROM. More information could be obtained from www.med.umich.edu/usrds. A link to this page could also be found on the NIDDK Web site at www.niddk.nih.gov/health/kidney/kidney.htm.
- NIDDK held a workshop in the fall of 1998 on critical issues in the care of dialysis patients, focusing on vascular access and nutrition. Participants in this workshop suggested that the Institute look at the epidemiology and basic mechanisms underlying malnutrition in ESRD patients and perhaps put out an RFA for a clinical trial in this area of nutrition.
- Dr. Briggs reported on two NIDDK initiatives in the area of polycystic kidney disease (PKD): (1) the establishment of interdisciplinary PKD research centers and (2) a cooperative agreement to establish innovative methods to image PKD and to use imaging to follow progression of the disease. NIDDK hoped this initiative would make the imaging methods precise and reproducible enough to be used as the outcome measure in a clinical trial.
- Dr. Jim Scherbenske reported NIDDK had scheduled a workshop for December 6-7, 1999, on simple kidney and transport systems, such as in yeast and drosophila.
- Dr. Paul Kimmel announced NIDDK was expecting applications in response to an RFA for research on genes associated with diabetic nephropathy and non-diabetic nephropathy.
- Dr. John Kusek reported that the Institute was expecting to release an RFA on vascular access in the near future. Also, he announced an upcoming workshop scheduled for September 27-28, 1999, on the epidemiology of chronic renal insufficiency (CRI), the ultimate goal being the development of a prospective cohort study on CRI.
Finally, Dr. Briggs mentioned that there is active interest among the renal professional societies and the National Kidney Foundation on the possibility of NIH or governmental agencies launching a national education program on kidney disease. There will be an NIH state-of-the-science meeting or a conference in FY 2000 on this topic.