Trial · NCT01791686
Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease
NCT01791686, Phase 1, Terminated, Celldex Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease. Trials, record NCT01791686. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01791686
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease
- NCT number
- NCT01791686
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 1 participants, actual
- Lead sponsor
- Celldex Therapeutics
- Conditions
- Dense Deposit Disease, Membranoproliferative Glomerulonephritis Type II, C3 Glomerulonephritis
- Interventions
- CDX-1135
- First posted
- 2013-02-15
- Last updated
- 2014-03-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety | From first study drug dose for up to 26 weeks | * 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 \[for patients ≥ 35 years of age\]. |
| Primary | C3 and AP Normalization | Regular assessments from study start up to 26 weeks | 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 | Duration of and time to normalize C3 and AP | Regular assessments from study start up to 26 weeks | 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. |
| Secondary | Renal Function | Regularly from study start up to 26 weeks | 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. |
| Secondary | Renal biopsy | Occurs up to 3 times from study start up to 26 weeks | 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. |
| Secondary | Immunogenicity | Regular assessments from study start up to 26 weeks | 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 | CDX-1135 concentrations | Regular assessments from study start up to 26 weeks | Serum concentrations of CDX-1135 will be determined from blood samples collected prior to dosing and post-dosing. (on each dosing day) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01791686
GET https://conductscience.org/api/trials/v1/NCT01791686/registered