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NCT00985426 · ClinicalTrials.gov registry record · Phase 3
Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients
A Phase 3 study of Chronic Kidney Disease, sponsored by Dynavax Technologies Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 521
- Enrollment target
- 1
- Study location
NCT00985426: Completed Phase 3 study of Chronic Kidney Disease, sponsored by Dynavax Technologies Corporation.
NCT00985426 is a Phase 3 study of Chronic Kidney Disease that has completed, run by Dynavax Technologies Corporation. The registered enrollment target is 521 participants, below the 3,202-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00985426, a Phase 3 study of Chronic Kidney Disease, has completed, sponsored by Dynavax Technologies Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 521 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.
Primary Outcome
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B compared to that after Engerix-B.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL HEPLISAV-B
- BIOLOGICAL Engerix-B
Study Locations (1)
Virginia
- Clinical Research Associates of Tidewater - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 521 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT00985426 record still lists
NCT00985426 is an interventional study that assigns participants to a tested intervention. The registered 521 participants enrollment target is mid-sized for trials with a published cap, below the 3,202-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Chronic Kidney Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00985426 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT00985426 about?
NCT00985426 is a clinical study titled "Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients". The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.
What is the current status of trial NCT00985426?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 521 participants. The study started on 2009-09. Estimated completion is 2012-01.
What conditions does trial NCT00985426 study?
This clinical trial studies the following conditions: Chronic Kidney Disease.
What interventions are being tested in trial NCT00985426?
The interventions under investigation include: Placebo (OTHER), HEPLISAV-B (BIOLOGICAL), Engerix-B (BIOLOGICAL).
Who is sponsoring clinical trial NCT00985426?
This trial is sponsored by Dynavax Technologies Corporation, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00985426 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Kidney Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00985426's enrollment target sits among peer trials
521 26th of 101 higher than 76 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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