Projects & Collaborations

Project List

Title RoleDesignPlanned EnrollmentActual Enrollment# of Sites
Minimize Menorrhagia in Women with Type 1 Von Willebrand Disease (VWDMin)DCC Purpose: The purpose of this Phase III multicenter prospective, randomized, crossover arm trial is to compare recombinant von Willebrand factor (rVWF) to tranexamic acid (TA) in reducing the severity of menorrhagia in women with von Willebrand disease.

Subjects randomized to Group I will receive Arm A, rVWF 40 IU/kg intravenously (IV) infusion on day 1 of each of two menstrual cycles. They will then be crossed over to Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5 of each of two menstrual cycles. Subjects randomized to Group II will receive Arm B, then be crossed over to Arm A.
60 women age 18-45 years with mild to moderate VWD and menorrhagia Ongoing 19
A Phase IIb Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Assess the Safety, Tolerability, and Efficacy of Riociguat in Patients with Sickle Cell Diseases (STERIO-SCD) DCC Purpose: phase II, multicenter trial to evaluate the safety and tolerability of 12-weeks of treatment with riociguat versus placebo in high-risk patients with sickle cell disease (SCD).

100 adults with sickle cell disease at high risk of sickle cell complications.
100 adults with sickle cell disease at high risk of sickle cell complications.Ongoing; commenced in Spring 201710
TAME-PKD: Trial of Administration of Metformin – Autosomal Dominant Polycystic Kidney DiseaseDCCPurpose: phase II, multicenter clinical trial to evaluate the safety and tolerability of metformin versus placebo over a two-year period.

Participants will be randomized in a 1:1 ratio to receive either placebo or metformin, titrated to 1000 mg twice daily, or maximal tolerated dose, over a 6-week period.
96 adults aged 18-60 with ADPKD.Ongoing; commenced in Spring 20162
A Clinical Research Study to HALT Progression of Polycystic Kidney Disease (HALT PKD Study A) DCC Purpose: to assess the efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD).

2x2 factorial design where participants were randomized to one of four study arms: 1) combination ACE-I/ARB with standard blood pressure (BP) control (systolic 120-130 and diastolic 70-80 mm Hg); 2) ACE-I monotherapy with standard BP control; 3) combination ACEI/ARB treated to a low BP target (systolic 95-110 and diastolic 60-75 mm Hg); and 4) ACE-I treated to the low BP goal. The primary outcome was the percent change in total kidney volume measured by magnetic resonance (MR) imaging.
558 participants with early disease defined by GFR >60 mL/min/1.73 m2. Completed7
A Clinical Research Study to HALT Progression of Polycystic Kidney Disease (HALT PKD Study B)DCCPurpose: to assess the efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD).

Participants were randomized to 1) ACE-I/ARB combination therapy or 2) ACE-I monotherapy to assess impact on composite endpoint of time to a 50% reduction of baseline eGFR, ESRD or death.
486 participants with moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2.Completed7

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