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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01791686
• Date of registration: 29/01/2013
• Prospective Registration: No
• Primary sponsor: Celldex Therapeutics
• Public title: Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease
• Scientific title: A Pilot, Open-label, Multicenter Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease
• Date of first enrolment: January 2013
• Target sample size: 1
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01791686
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Carla Nester, MD, MSA
• Affiliation: University of Iowa

• Name: Richard Smith, MD
• Affiliation: University of Iowa

Key inclusion & exclusion criteria

Inclusion Criteria:

Among other criteria, patients must be

1. Patient and/or parent/legal guardian (as appropriate) must give written informed
consent

2. Four (4) years of age or older

3. 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

4. Signs of abnormal complement pathway activity

5. Serum creatinine level must be abnormal

6. Screening lab values criteria:

1. Hgb = 9.0 g/dL

2. Platelets = 100,000/mm^3

3. ALT and AST = 3.0 x upper limit of normal

4. C3 serum <50% of the lower limit of normal

5. 24 hour urine protein >1000 mg/day, or urine protein:creatinine ratio >1.0

7. 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

8. 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

9. 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

1. Dialysis or a low estimated glomerular filtration rate <30 ml/min/1.73m^2 over a
4-week period prior to Screening

2. Active or untreated systemic bacterial infection

3. Pregnant or lactating

4. Rituximab therapy (unless discontinued with B cell levels and immunoglobulin levels
normalized by study entry)

5. 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)

6. 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

7. 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

8. Preexisting condition with an association as a potential cause of DDD (i.e.,
Monoclonal Gammopathy of Undetermined Significance) or an alternate glomerular
disease

9. 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

10. Myocardial infarction within 1 year of screening, congestive heart failure,
arrhythmia persistent on medication at screening or chronic lung disease

11. Known HIV, Hepatitis B or Hepatitis C

12. 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



Age minimum: 4 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Dense Deposit Disease

C3 Glomerulonephritis

Membranoproliferative Glomerulonephritis Type II

Intervention(s)

Drug: CDX-1135

Primary Outcome(s)

Safety [Time Frame: From first study drug dose for up to 26 weeks]

C3 and AP Normalization [Time Frame: Regular assessments from study start up to 26 weeks]

Secondary Outcome(s)

Immunogenicity [Time Frame: Regular assessments from study start up to 26 weeks]

Renal biopsy [Time Frame: Occurs up to 3 times from study start up to 26 weeks]

Duration of and time to normalize C3 and AP [Time Frame: Regular assessments from study start up to 26 weeks]

Renal Function [Time Frame: Regularly from study start up to 26 weeks]

Secondary ID(s)

CDX1135-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors