Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease (NCT01791686) | Clinical Trial Compass
TerminatedPhase 1
Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease
Stopped: Portfolio prioritization due to slow enrollment and variable spectrum of potential complement abnormalities in DDD patients.
United States1 participantsStarted 2013-01
Plain-language 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.
Who can participate
Age range4 Years
SexALL
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Inclusion criteria
✓. 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:
✓. Hgb ≥ 9.0 g/dL
✓. Platelets ≥ 100,000/mm\^3
Exclusion criteria
✕. Dialysis or a low estimated glomerular filtration rate \<30 ml/min/1.73m\^2 over a 4-week period prior to Screening
✕
What they're measuring
1
Safety
Timeframe: From first study drug dose for up to 26 weeks
2
C3 and AP Normalization
Timeframe: Regular assessments from study start up to 26 weeks
. Active or untreated systemic bacterial infection
✕. Pregnant or lactating
✕. Rituximab therapy (unless discontinued with B cell levels and immunoglobulin levels normalized by study entry)
✕. Immunosuppressive therapies (except for low dose steroids \[≤10 mg per day\] given for non-DDD related conditions such as asthma). Exceptions will be made for renal transplant patients, who may receive any appropriate therapies as needed to maintain the transplant (i.e., to prevent rejection)
✕. Treatment with any complement inhibitor within 3 months of study entry or any other investigational drug, device, or experimental procedure within 4 weeks prior to enrollment
✕. For renal transplant patients only: histology findings of treatable rejection (i.e. that the usual transplant physician would seek to treat). Chronic allograft nephropathy is not exclusionary provided the patient's glomerular filtration rate meets other entry criteria
✕. Preexisting condition with an association as a potential cause of DDD (i.e., Monoclonal Gammopathy of Undetermined Significance) or an alternate glomerular disease