CLDX begins recruiting patients in dense deposit disease trial
Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease
This study is currently recruiting participants.
Verified February 2013 by Celldex Therapeutics
Sponsor:
Celldex Therapeutics
Information provided by (Responsible Party):
Celldex Therapeutics
ClinicalTrials.gov Identifier:
NCT01791686
First received: January 29, 2013
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
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Purpose
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 at the University of Iowa. The Induction Period is up to 4 weeks. Following normalization of complement activity, patients will enter into the Maintenance Period. The first week of the Maintenance Period will also be conducted at the University of Iowa, after which time the patient may be able to be treated at an institution more local to them. The total treatment duration is up to 26 weeks.
Condition Intervention Phase
Dense Deposit Disease
Drug: CDX-1135
Phase 1
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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
Resource links provided by NLM:
Genetics Home Reference related topics: dense deposit disease
U.S. FDA Resources
Further study details as provided by Celldex Therapeutics:
Primary Outcome Measures:
Safety [ Time Frame: From first study drug dose for up to 26 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
Duration of and time to normalize C3 and AP [ Time Frame: Regular assessments from study start up to 26 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Other Outcome Measures:
CDX-1135 concentrations [ Time Frame: Regular assessments from study start up to 26 weeks ] [ Designated as safety issue: No ]
Serum concentrations of CDX-1135 will be determined from blood samples collected prior to dosing and post-dosing. (on each dosing day)
Estimated Enrollment: 5
Study Start Date: January 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 for each subsequent dose, up to a maximum dose of 30 mg/kg. This period may last up to 4 weeks. The entire Induction Period will be conducted at the University of Iowa.
? 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. The first week of the Maintenance Period will be conducted at the University of Iowa.
Drug: CDX-1135
Other Names:
TP10
sCR1
Eligibility
Ages Eligible for Study: 4 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
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)
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
ALT and AST = 3.0 x upper limit of normal
C3 serum <50% of the lower limit of normal
24 hour urine protein >1000 mg/day, or urine protein:creatinine ratio >1.0
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
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)
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
Prior renal transplant
Preexisting condition with an association as a potential cause of DDD (i.e., Monoclonal Gammopathy of Undetermined Significance) or an alternate glomerular disease
Cancer except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer that the patient has been disease-free for = 5 years
Myocardial infarction within 1 year of screening, congestive heart failure, arrhythmia persistent on medication at screening or chronic lung disease
Known HIV, Hepatitis B or Hepatitis C
Any medical or psychological condition that would increase the patient's risk by being in this study or would interfere with interpretation of the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01791686
Contacts
Contact: Celldex Therapeutics Info@celldextherapeutics.com
Locations
United States, Iowa
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Carla Nester, MD, MSA 319-353-7335 carla-nester@uiowa.edu
Contact: Douglas Russo, BA 319-467-5109 douglas-russo@uiowa.edu
Principal Investigator: Carla Nester, MD, MSA
Sponsors and Collaborators
Celldex Therapeutics
Investigators
Principal Investigator: Carla Nester, MD, MSA University of Iowa
Principal Investigator: Richard Smith, MD University of Iowa
More Information
No publications provided
Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT01791686 History of Changes
Other Study ID Numbers: CDX1135-01
Study First Received: January 29, 2013
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration
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