Current/Unpublished SPNSG Studies

This page gives a brief overview of the studies that are ongoing - or have been completed but not yet published. Summaries of some of the study protocols may be reviewed by clicking on the specific study title.

A.  A Randomized, Placebo-Controlled, Multicenter Trial Evaluating Alternate Day Prednisone or Omega-3 Fatty Acids in Young Patients with IgA Nephropathy (IgAN)

The IgA Nephropathy Study is now in its seventh year of operation. It is funded by the National Institutes of Health and conducted in patients with IgA Nephropathy up to 41 years of age, in pediatric and adult nephrology centers across the United States and Canada. The results of the study will be analyzed in the first quarter of 2003.

B.  A Randomized Placebo-Controlled Trial of Mycophenolate Mofetil in Patients with IgA Nephropathy

Our next major study in patients with IgA Nephropathy represents a new venture for our participating centers in two respects; firstly , the patients will be aged up to 70 years of age, and secondly, the study will involve multiple medications in an attempt to provide a comprehensive approach to the management of this condition. The study has been made possible by a grant from Roche Laboratories. Merck and Pronova Biocare have also donated medications. We anticipate that the study will be open for patient enrollment in the 2^nd quarter of 2002 and will be completed at the end of 2005. The protocol for this study will be posted on this website in March 2002.

C.  Immunogenicity of VARIVAX® in Children with Chronic Renal Insufficiency

Concern about the serious consequences that may be associated with varicella infections in children with kidney transplants led to the development of this study. Sponsored by a grant from Merck Laboratories and led by Drs. Barbara Fivush and Susan Furth at Johns Hopkins University, this study has evaluated the response to VARIVAX^® in children with various degrees of chronic kidney failure, including those on dialysis therapy. Some of the patients also had varicella antibody levels measured after they received a kidney transplant (but no patient received the VARIVAX^® post-transplant). The results have now been analyzed and a report will be submitted for publication in the near future.

D.  Safety, Tolerability and Immunogenicity of VARIVAX® in Children with Nephrotic Syndrome

Chickenpox can also represent a serious threat to children with nephrotic syndrome, especially while they are being treated with steroids. This study, which evaluated antibody responses to VARIVAX^® in children with NS (on or off steroids) has also been made possible by a grant from Merck Laboratories and led by the same team at Johns Hopkins University. The study was conducted mainly in our participating centers in Canada with a high percentage being recruited in Ontario. The results of this study will also be submitted for publication in the next few months.

E.  Long versus Standard Initial Steroid Therapy for Childen with the Nephrotic Syndrome

The dilemma surrounding optimum duration of the initial course of steroid therapy in children with nephrotic syndrome has puzzled pediatric nephrologists for years. This study, led by Dr. Marc Lande, evaluated the potential benefits and side effects associated with a more prolonged initial course of treatment versus the standard approach published previously by the International Study of Kidney Disease in Children. The results have been submitted for publication.

F.  Pilot Study of Mycophenolate (MMF) in Children with Steroid-Dependent Nephrotic Syndrome (SDNS)

Many of our patients with nephrotic syndrome require multiple courses of steroids to keep them in remission. This has led to the use of a variety of other "steroid-sparing" medications, some of which may have more serious long-term side effects than the disorder being treated. In this study, we are evaluating whether mycophenolate mofetil is able to maintain children in remission from their NS. The study has been made possible by a grant from Roche Laboratories. Patient enrollment has been completed. Data analysis will be done in the first quarter of 2003. A summary of the current status of the study is provided in this month's edition of "SPNSG SPECTRUM"

G.  Molecular Determinants in Children with D+ HUS

Infants and children who develop acute kidney failure from the Hemolytic Uremic Syndrome, associated with E. coli 0157 infection, usually have a significant improvement in their kidney function - for reasons that are not entirely clear to us. In this study, led by Dr. Phillip Tarr at the University of Washington in Seattle, we are evaluating why this occurs by measuring a large number of potential factors in the blood of children with HUS during both their acute illnes - and their recovery phase. Our subsequent goal would be to use the information to develop better treatment for this condition. Results of the study are now being analyzed by Dr. Tarr.

H.  Response to Recombinant Hepatitis B Vaccine in Children and Adolescents with Chronic Renal Failure