Selected Publications
Vaziri-Sani F, Stahl A, Kristoffersson A, Gydell K, Raafat R, Gutierrez A, Beringer O, Zipfel P, Karpman D. Factor H dysfunction in serum from patients with atypical hemolytic Uremic Syndrome contributes to Complement deposition and platelet activation. Submitted to Blood, October 2006.
Vaziri-Sani F, Holmberg L, Sjöholm AG, Kristoffersson AC, Manea M, Frémeaux-Bacchi V, Fehrman-Ekholm I, Raafat RH, Karpman D. Phenotypic expression of factor H mutations in patients with atypical hemolytic uremic syndrome. Kidney Int 2006 Mar;69(6):981-988.
Raafat RH, Kalia A, Travis LB, Diven SC. High-dose oral cyclosporin therapy for recurrent focal segmental glomerulosclerosis in children. Am J Kidney Dis 2004 Jul;44(1):50-56.
Raafat RH, Travis LB, Kalia A, Diven S. Role of transplant induction therapy on recurrence rate of focal segmental glomerulosclerosis. Pediatr Nephrol 2000 Mar;14(3):189-194
RESEARCH GRANTS
Federal
Funding Agency: NIH
Title: Focal Segmental Glomerulosclerosis Trial
Status: Active
Period: 06/2004 – 08/2006
Role: Co-Investigator                                     Â
Total Costs: $16,700.00
Grant Detail: The experimental design is a multi-center, prospective controlled, open label randomized trial comparing two treatment regimens, Cyclosporin A (CSA) and Mycophenolate Mofetil (MMF)/pulse steroids in 2 - 40 year old subjects. The CSA and MMF/pulse steroid treatment regimens will be implemented over the first 52 weeks after randomization. The primary outcome is based on the achievement of remission from proteinuria.
Funding Agency: NIH
Title: (SWO1) A Double-Blind, Randomized Trial of Steroid Withdrawal in Sirolimus- and Cyclosporine- Treated Primary Transplant Recipients
Status: Active
Period: 01/2001 – 08/2006
Role: Co-Investigator                     Â
Total Costs: $39,500.00
Grant Detail: This study is a multi-center randomized, double-blind trial in which corticosteroids will be eliminated from immunosuppressive regimen in patients under 21 years old. Patients will be followed for 3 years. Primary objectives are to compare the frequency and severity of rejection in the two study arms and to compare graft survival and renal function as measured by the calculated creatinine clearance. Secondary objectives are to compare following steroid withdrawal, the growth velocity, lipid profile and blood pressure in the two study arms.
Funding Agency: NIH
Title: (INO1) Controlled Trial of Induction Therapy in Renal Transplantation
Status: Complete
Period: 05/1998 - 01/2006
Role: Co-Investigator                                  Â
Total Costs: $6,000.00
Grant Detail: This multi-center study compared kidney transplant outcome in children less than 17 years old and received immunosuppression induction with mouse monoclonal antibody OKT3 to those who received intravenous Cyclosporine A infusion over the first 24 hours after transplantation. Other immunosuppressive medications were similar in both groups. Both groups will eventually start Cyclosporine A. OKT3 induction group will start Cyclosporine A at day 8 post transplant and IV Cyclosporine group will start at day 3 post transplant.
Funding Agency: NIH
Title: North American Pediatric Renal Transplant Cooperative Study (NAPRTCS)
Status: Active
Period: 08/1995 – 08/2006
Role: Co-Investigator                            Â
Total Costs: $6,300.00
Grant Detail: National registry of patients under 21 years old with chronic renal insufficiency, peritoneal dialysis, hemodialysis and kidney transplantation.
Private
Funding Agency: AstraZeneca Pharmaceuticals LP
Title: (261A) A Dose-Ranging and Safety Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to < 6 Years of Age: A 4-Week, Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study
Status: Active
Period: 03/2005 – 08/2006
Role: Co-Investigator                                      Â
Total Costs: $24,960.00
Grant Detail: This is a double-blind, placebo controlled multicenter study of the antihypertensive agent candesartan cilexetil in children one year to less than 6 years of age. It examines dosage and safety over a 4 week period.
Funding Agency: AstraZeneca Pharmaceutical LP
Title: (261B) Multicenter, Multinational, Open-Label Study of Efficacy, Safety and Pharmacokinetics of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to < 6 Years of Age
Status: Active
Period: 03/2005 – 08/2006
Role: Co-Investigator                                     Â
Total Costs: $54,600.00
Grant Detail: This is an open-label extension of the 261A study. It examines the efficacy and safety over 52 weeks. It also examines pharmacokinetics of Candesartan Cilexetil in the hypertensive young patient.
Funding Agency: AstraZeneca Pharmaceutical LP
Title: (307B) A Study of A Safety and Tolerability of TOPROL-XL (metoprolol succinate) Extended-Release Tablets (metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Open Label Extension of Protocol 307A.
Status: Active
Period: 06/2002 – 08/2006
Role: Co-Investigator                                           % Effort: 2
Total Costs: $52,500.00
Grant Detail: This is an open label extension of 307A study protocol to study the safety and tolerability of Metoprolol Succinate extended release tablets in 6 to 16 year old pediatric subjects. Patients were monitored for 52 weeks.
Funding Agency: AstraZeneca Pharmaceutical LP
Title: (307A) A Study of Dose Ranging, Safety and Tolerability of TOPROL-XL (metoprolol succinate) Extended-Release Tablets (metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel Group Study
Status: Active
Period: 06/2002 – 08/2006
Role: Co-Investigator        Â
Total Costs: $23,500.00
Grant Detail: This is a double blind, placebo controlled randomized trial of Metoprolol Succinate in hypertensive children 6 - 16 years old. It is a study of dosage, safety and tolerability. Recruited patients are either newly diagnosed and untreated or previously diagnosed and currently treated with a mean sitting systolic or diastolic blood pressure at or above the 95th percentile.
Funding Agency: AMGEN
Title: An Open-Label, Randomized, Non-Inferiority Study of Novel Erythropoiesis Stimulating Protein (NESP) and Recombinant Human Erythropoietin (r-HuEPO) for the Treatment of Anemia in Pediatric Subjects with Chronic Renal Insufficiency (CRI) or End Stage Renal
Status: Complete
Period: 01/2001 - 09/2005
Role: Co-Investigator                                  Â
Total Costs: $86,827.59
Grant Detail: This is an open-label, randomized trial in children between the ages of 1 and 18 years who are either on dialysis or with chronic renal insufficiency. It compared anemia response to Erythropoiesis stimulating protein (NESP) and Human Erythropoietin (r-HuEPO). Subjects were monitored for 29 weeks.
Funding Agency: Wyeth
Title: (SRL1) An Open-Label Comparative Study of the Effect of Sirolimus Versus Standard Treatment Clinical Outcomes
Status: Complete
Period: 09/1999 - 09/2005
Role: Co-Investigator                    Â
Total Costs: $6,325.00
Grant Detail: This multi-center study compared the safety and efficacy of Rapamycin when added to Cyclosporine A (CyA) or Tacrolimus and corticosteroids versus standard CyA or Tacrolimus based therapy in less than 21 year old renal transplant patients. Patients were monitored for 36 months. Efficacy was assessed by comparing the composite endpoint of biopsy proven acute rejection, graft loss, or death. |