BIIB
Aims: This is a 72 week multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of BIIB023 in subjects with newly diagnosed lupus nephritis.
Diagnosis: Lupus Nephritis
Principal Investigator: Neenoo Khosla, MD
IRB Approval Number: EH 12-364
Sponsor: Biogen Idec
Contact: For more information, interested participants and clinicians may contact the Nephrology Research Office at 847.570.1761 or email Shonny Fettman at sfettman@northshore.org.
Open to Enrollment: Yes
CTAP
Aims: A multi-centered, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CTAP101 capsules to treat secondary hyperparathyroidism in subjects with stage 3 or 4 Chronic Kidney Disease and Vitamin D insufficiency. It includes 9 weeks of screening for participation (including washout); 26 weeks of study drug and a week of follow-up. There are 14 study visits each lasting 30-60 minutes.
Diagnosis: Chronic Kidney Disease Stage 3 or 4; Vitamin D insufficiency
Principal Investigator: Stuart Sprague, DO
IRB Approval Number: EH 11-004
Sponsor: Cytochroma
Contact: For more information, interested participants and clinicians may contact the Nephrology Research Office at 847.570.1761 or email Sangeeth Rao at SRao@northshore.org.
Open to Enrollment: Yes
KAI 416
Aims: A randomized, double-blind, placebo controlled, phase 3 Study to access the efficacy and safety of AMG 416 in the treatment of secondary hyperparathyroidism in subjects with chronic kidney disease on hemodialysis. This study will enroll patients with hyperphosphatemia who are on in-center hemodialysis at least three times per week. Participation in this study will last approximately 6 months with an optional 6 month open label extension study.
Diagnosis: End Stage Renal Disease and Secondary Hyperparathyroidism
Principal Investigator: Stuart Sprague, DO
IRB Approval Number: EH 11-004
Sponsor: Amgen
Contact: For more information, interested participants and clinicians may contact the Nephrology Research Office at 847.570.1761 or email Shonny Fettman at sfettman@northshore.org.
Open to Enrollment: Yes
START; Strategies Using Darpepoetin alfa to Avoid Transfusions in Chronic Kidney Disease
Aims: This is a two year study comparing two different dosing strategies using Aranesp for the treatment of anemia in patients with Chronic Kidney Disease.
Diagnosis: Anemia; Chronic Kidney Disease
Principal Investigator: Stuart Sprague, DO
IRB Approval Number: EH 12-235
Sponsor: Amgen Inc
Contact: For more information, interested participants and clinicians may contact the Nephrology Research Office at 847.570.1761 or email Shonny Fettman at sfettman@northshore.org.
Open to Enrollment: Yes
Biodensity
Aims: This is a pilot study to investigate the effects of a resistance training device, Biodensity, on biochemical and functional parameters in End Stage Kidney Disease patients receiving dialysis therapy.
The primary outcome of the study will include baseline and 6 month DXA scan results. The goal will be >3% increase of bone density at either the hip or spine. The secondary outcomes will be changes in biochemical parameters of hemoglobin and dialysis efficiency as measured by kt/v, serum bicarbonate, albumin, parathyroid hormone, C-reactive protein and hemoglobin.
Diagnosis: Chronic Kidney Disease on Hemodialysis or Peritoneal Dialysis
Principal Investigator: Stuart Sprague, DO
IRB Approval Number: EH 11-172
Sponsor: Cytochroma
Contact: For more information, interested participants and clinicians may contact the Nephrology Research Office at 847.570.1761 or email Shonny Fettman at sfettman@northshore.org.
Open to Enrollment: Yes