Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease
|Dense Deposit Disease Membranoproliferative Glomerulonephritis Type II C3 Glomerulonephritis||Drug: CDX-1135||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot, Open-label, Multicenter Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease|
- Safety [ Time Frame: From first study drug dose for up to 26 weeks ]
- Incidence and severity of adverse events (AE) will be assessed at every visit. AEs and serious adverse events (SAEs) will be assessed from the first dose of study drug through 33 days after the last dose
- To evaluate the safety of repeated dosing in patients with DDD. Safety will be assessed based on changes in clinical laboratory tests, physical exams, vital signs, ophthalmic exams and ECGs [for patients ≥ 35 years of age].
- C3 and AP Normalization [ Time Frame: Regular assessments from study start up to 26 weeks ]The proportion of patients with normalization of serum C3, serum C3 breakdown products, or alternative pathway (AP) complement activity. These blood tests will be assessed on each dosing day and upon Study Completion /Termination.
- Duration of and time to normalize C3 and AP [ Time Frame: Regular assessments from study start up to 26 weeks ]Time to normalization of serum levels of C3 or C3 breakdown products and duration of normalization and assays of alternative pathway activity. These blood tests will be assessed on each dosing day and upon Study Completion /Termination.
- Renal Function [ Time Frame: Regularly from study start up to 26 weeks ]Stabilization and/or improvement in renal function (as measured by serum creatinine and proteinuria). These lab tests will be performed weekly during the Induction Period, monthly during the Maintenance Period and upon Study Completion /Termination.
- Renal biopsy [ Time Frame: Occurs up to 3 times from study start up to 26 weeks ]Improvement on renal biopsy (as measured by reduction in C3 deposition in the glomerular basement membrane). This biopsy may be performed during screening, week 13, and upon Study Completion /Termination.
- Immunogenicity [ Time Frame: Regular assessments from study start up to 26 weeks ]Immunogenicity (development of antibodies to CDX-1135). This sample will be collected prior to dosing on Week 1, monthly during treatment, and upon Study Completion /Termination
- CDX-1135 concentrations [ Time Frame: Regular assessments from study start up to 26 weeks ]Serum concentrations of CDX-1135 will be determined from blood samples collected prior to dosing and post-dosing. (on each dosing day)
|Study Start Date:||January 2013|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Dense Deposit Disease
► Induction Period
Patients will receive CDX-1135 as an IV infusion twice weekly (Mon-Thur or Tues-Fri). There will be two doses of 5 mg/kg, with intrapatient dose-escalation in 5 mg/kg increments up to a maximum dose of 30 mg/kg. This period may last up to 8 weeks.
► Maintenance Period
The starting dose for CDX-1135 Maintenance will be the same dose level as the last dose during the Induction Period; however, the Maintenance Period allows for dose decrease to 2 mg/kg, which is lower than the starting dose in the Induction Period.
Patients will receive CDX-1135 as an IV infusion twice weekly (Mon-Thur or Tues-Fri) for up to a total of 26 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01791686
|United States, Iowa|
|University of Iowa Hospitals & Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Carla Nester, MD, MSA||University of Iowa|
|Principal Investigator:||Richard Smith, MD||University of Iowa|