Clinical Trial: Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Pilot, Open-label, Multicenter Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease

Brief Summary: This study is evaluating the study drug (CDX-1135) in patients with dense deposit disease (DDD). The objective is to evaluate the safety and activity of repeated doses of CDX-1135 in pediatric and adult patients with DDD. After screening, eligible patients will be entered into the Induction Period. The Induction Period is up to 4 weeks. Following normalization of complement activity, patients will enter into the Maintenance Period.The total treatment duration is up to 26 weeks.

Detailed Summary:
Sponsor: Celldex Therapeutics

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Celldex Therapeutics

Dates:
Date Received: January 29, 2013
Date Started: January 2013
Date Completion:
Last Updated: March 6, 2014
Last Verified: March 2014