Research

Research is the cornerstone of medicine and clinical trials are the proving ground for modern medications and treatment.  One of the strengths of SCSP is our commitment to medical research.

SCSP is dedicated to advancing the science of medicine.  Our doctors and nurses work together to offer patients access to clinical trials.  Clinical trials are research studies that explore new ways to treat and/or cure disease, and improve quality of life; and are the key to advancing medicine.

Making sure participants are safe is the top priority in all clinical trials.  In addition, an independent committee must, according to FDA regulations, oversee all clinical trials for the entire duration of the study.  This committee consists of doctors, experts, and community advocates.  It is their responsibility to make sure patient rights and safety are protected.

Individuals who choose to participate in clinical trials are given the opportunity to benefit from treatments that are not currently available to the general public, but have shown promise in previous research.  SCSP offers clinical trials that study a variety of disease entities including: anemia, dialysis, hypertension, and transplantation.

If you are interested in more information, please contact your SCSP physician to determine if we have a clinical trial that may be of benefit to you.

SCSP is currently involved with the following clinical trials:

Altitude
Primary Investigator: Dr. Susan Steigerwalt
Coordinator:  Sherry Gasko, RN
Objective: A randomized, double-blind, placebo-controlled, parallel-group study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality.

ACT 401
Primary Investigator:  Dr. Joel Topf
Coordinator:  Lori McFadden, RN
Objective:  An open, randomized, controlled, parallel group, Phase III study to investigate the safety and efficacy of magnesium iron hydroxycarbonate and lanthanum carbonate in hemodialysis patients with hyperphosphatemia.  This study will begin enrollment in June at the DaVita dialysis centers.

Fibrogen CKD Protocol
Primary Investigator:  Dr. Robert Provenzano
Coordinator:  Paula LaFleur, RN
Objective:  A randomized, single blind, placebo-controlled, 4-week treatment study of the safety and biologic activity of escalating multiple oral doses of FG-4592 in subjects with chronic kidney disease not requiring dialysis. Please refer any pt with a hgb < 11.0 requiring ESA therapy.

Rapamune Study
Primary Investigator: Dr. Mohamed El-Ghoroury
Coordinator: Sherry Gasko, RN
Objective: A randomized placebo controlled double-blend comparative study evaluating the effect of Ramipril on urinary protein excretion in maintenance renal transplant patients converted to Sirolimus.  Our site is currently the highest enrolling site for the study.

Rapamune II Study
Primary Investigator: Dr. Mohamed El-Ghoroury
Coordinator: Sherry Gasko, RN
Objective:  To evaluate whether planned transition between 90 and 150 days post-transplantation to SRL-based therapy from TAC-based therapy is associated with a clinically relevant degree of improvement in renal function (≥ 5.0 mL/min/1.73 m2) compared to continuation of TAC-based therapy. To evaluate the safety of planned transition between 90 and 150 days post-transplantation to SRL-based therapy from TAC-based therapy.

C-Probe Study
Primary Investigator:  Dr. Susan Steigerwalt
Coordinator:  Sherry Gasko, RN
Objective:  The primary goal of C-Probe is to develop an infrastructure that will serve as an interface between pts. in the clinical care settings in South East Michigan and biomedical investigators conducting translational research in kidney disease.  This is an exciting endeavor between the St. Clair Specialty Physicians, University of Michigan, Wayne State University, and University of Illinois.