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 range
4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. Dialysis or a low estimated glomerular filtration rate \<30 ml/min/1.73m\^2 over a 4-week period prior to Screening
. 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