End Stage Renal DiseasePhase 2/3NCT02032095
The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
A Phase 2/3 study testing GB-0998 in people with End Stage Renal Disease, run by Japan Blood Products Organization at 1 site in Japan.
Trial summary
It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- GB-0998
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2013to Sep 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage 4 or 5 on the CKD classification.
- Of the patients that wants a living-donor kidney transplant of ABO blood type compatible, patients with positive FCXM-T and negative CDC-T to the donor.
- Patients with positive FCXM-T after performing twice DFPP therapy
Who cannot join
- Patients who had taking to continue immunosuppressive drugs or steroids within 4 weeks before obtaining informed consent.
- Patients who had IVIG therapy, or plasmapheresis therapy within 12 weeks before to informed consent.
- Patients who had Rituximab within 6 month before to informed consent.
- Patients who have undergone splenectomy.
- Patients with severe hepatic disorder or severe heart disorder.
- Patients with receiving treatment of malignancy.
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- Patients with high risk of thromboembolism.
- Patients with history of shock or hypersensitivity to GB-0998.
- Patients with hereditary fructose intolerance or IgA deficiency.
- Patients with pregnant or probably pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization. Patients with positive FCXM-T after performing twice double filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.
- Conditions
- End Stage Renal Disease
- Being tested
- GB-0998
- Keywords
- IVIG, Renal transplantation, desensitization
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB-0998Drug
Also called Intravenous immunoglobulin (Venoglobulin IH)
| Study group | Role | What they receive |
|---|---|---|
| GB-0998 | Experimental | Not described Receives: Drug: GB-0998 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative rate of FCXM-T after the fourth administration of GB-0998
Measured: at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Blood Products Organization
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032095
- Sponsor's protocol ID
- B211-10
- Status last verified
- Feb 2016
- First submitted
- 8 Jan 2014
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
- ClinicalTrials.gov ID
- NCT02032095
- Acronym / sponsor ID
- B211-10
- Conditions
- End Stage Renal Disease
- Keywords
- IVIG, Renal transplantation, desensitization
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Japan Blood Products OrganizationIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization. Patients with positive FCXM-T after performing twice double filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GB-0998 | Experimental | Drug: GB-0998 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with stage 4 or 5 on the CKD classification.
- Of the patients that wants a living-donor kidney transplant of ABO blood type compatible, patients with positive FCXM-T and negative CDC-T to the donor.
- Patients with positive FCXM-T after performing twice DFPP therapy
Key exclusion criteria (10 listed)
- Patients who had taking to continue immunosuppressive drugs or steroids within 4 weeks before obtaining informed consent.
- Patients who had IVIG therapy, or plasmapheresis therapy within 12 weeks before to informed consent.
- Patients who had Rituximab within 6 month before to informed consent.
- Patients who have undergone splenectomy.
- Patients with severe hepatic disorder or severe heart disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB-0998Also: Intravenous immunoglobulin (Venoglobulin IH) | Drug | GB-0998 |
Primary outcome
Negative rate of FCXM-T after the fourth administration of GB-0998
Time frame: at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GB-0998 in people with End Stage Renal Disease, run by Japan Blood Products Organization at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative rate of FCXM-T after the fourth administration of GB-0998 (time frame: at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.