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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.
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Inclusion criteria
Among other criteria, patients must be
Patient and/or parent/legal guardian (as appropriate) must give written informed consent
Four (4) years of age or older
Must have DDD, confirmed by renal biopsy within 6 months of study enrollment (Confirmation by University of Iowa investigators is required). If the patient is post transplant, the repeat renal transplant biopsy must show C3 dominant glomerulonephritis, and the patient must have a history of known DDD in the native kidney
Signs of abnormal complement pathway activity
Serum creatinine level must be abnormal
Screening lab values criteria:
Both male and female patients of childbearing potential enrolled must use adequate birth control during the trial and for 1 month after stopping study drug
Willing and able to comply with study procedures, including pre-study vaccinations (meningitis, haemophilus and pneumococci) and agree to a renal biopsy at Week 13 and at the end of the study
Any anti-proteinuric medications (eg, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers) must be at a stable dose for 4 weeks prior to first dose of CDX-1135
Exclusion criteria
Among other criteria, patients must not be
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1 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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