Clinical Research
Dr.
Dennis Black, Scientific Director of the CFRC, has made a concerted
effort to increase the amount of clinical research supported by the Center.
To do this, he first conducted an informal survey of all of the faculty
members to try to identify the barriers that existed for carrying out
clinical studies. Actual funding for carrying clinical studies from sources
such as pharmaceutical companies, the NIH and other sources really did
not seem to be a major barrier. The major problems fell into two categories.
First, many studies require only half of a research nurse's time for maybe
a six month period to carry out a clinical study. It is extremely difficult,
obviously, to secure such nursing support on a consistent basis. Secondly,
all human research must go through the UT Institutional Review Board,
which is a complex and daunting process for a new investigator just beginning
to undertake a career in clinical research. To overcome these problems,
a CFRC Office of Clinical Research was established under the direction
of Dr. Robert Wyatt. Dr. Kimberly Fisher, who has a Ph.D. in nursing and
extensive experience in carrying out clinical research protocols, was
recruited for this new Center. Also, she has expertise in the preparation
and submission of Institutional Review Board human research applications.
Sandy Grimes, RN, is a CFRC Clinical Study Nurse and Coordinator who also
assists clinical investigators.
The Office of Clinical Research is currently conducting these studies:
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. Dr. Robert Wyatt is working
on this study with other researchers as shown on the SPNSG (Southwest
Pediatric Nephrology Study Group).
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 2nd 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. Dr. Robert Wyatt is conducting this study with
other doctors from the SPNSG (Southwest Pediatric Nephrology Study Group).
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. Dr.
Bettina Ault is studying MMF with other doctors from the SPNSG (Southwest
Pediatric Nephrology Study Group).
