Chronic RejectionNCT01052259
Efficacy and Safety of Deoxyspergualin in Renal Transplant Patient With Chronic Rejection
A study testing Deoxyspergualin in people with Chronic Rejection, run by Nippon Kayaku Co., Ltd. at 8 sites in Japan.
Trial summary
The purpose of this study to examine the efficacy and safety of cycling treatment of deoxyspergualin in renal transplant patients with biopsy-proven chronic rejection. Read more about this study
- Who is it for?
- Ages 11 to 70 years
- Conditions the study is for
- Chronic Rejection
- What is being tested?
- Deoxyspergualin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 8 sitesJapan
- Study dates
- Jun 2009to Dec 2012
- Phase
- Interventional
- 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 11 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic rejection defined by Banff 2007 criteria
Who cannot join
- Patients who have recurrent renal diseases and virus-associated renal diseases
- Patients who have initial WBC < 4,000, neutrophil < 1,000 , platelet < 50,000 or Hb < 8g
- Patients who have acute or chronic infection
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Akita University School of Medicine
Akita, Akita, 010-8543
Graduate School of Medicine Sciences, Kyushu University
Fukuoka, Fukuoka, 812-8582
Gifu University Graduate School of Medicine
Gifu, Gifu, 501-1194
Toho University Graduate School of Medicine
Ōta-ku, Tokyo, 143-8541
Sapporo City General Hospital
Sapporo, Hokkaido, 060-8604
Tokyo Women's Medical University
Shinjuku-ku, Tokyo, 162-8666
Osaka University Graduate School of Medicine
Suita, Osaka, 565-0871
Toda Central General Hospital
Toda, Saitama, 335-0023
About this study
Official title: Pilot Study of Cycling Treatment of Deoxyspergualin in Biopsy-proven Chronic Rejection of Kidney Transplantation
The purpose of this study to examine the efficacy and safety of cycling treatment of deoxyspergualin in renal transplant patients with biopsy-proven chronic rejection.
Read the detailed description
The primary aim of this study is to investigate the efficacy of deoxyspergualin after the completion of 6 cycles treatment. The efficacy valuables are histological findings in renal grafts, renal function, proteinuria, graft survival, anti-HLA antibody. The safety data are also evaluated in the study.
- Conditions
- Chronic Rejection
- Being tested
- Deoxyspergualin
- Keywords
- Chronic rejection, Kidney, Transplantation, Immunosuppressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeoxyspergualinDrug
Also called Spanidin, gusperimus hydrochloride
100mg/vial as active substance; Deoxyspergualin at 3-5 mg/kg/day by 1-3 iv infusion will be given once a day for 5 to 7 days each cycle every month; Total cycle treatment will be 6.
| Study group | Role | What they receive |
|---|---|---|
| Deoxyspergualin, Treatment, | Experimental | Not described Receives: Drug: Deoxyspergualin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathological findings by Banff criteria
Measured: 6 month after treatment initiation
Secondary outcomes (1)
Renal function, proteinuria, graft survival, anti-HLA antibody, adverse events, serious adverse events (SAE)
Measured: 6 and 12 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Insufficient patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RejectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nippon Kayaku Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hiroshi Harada, Chief, Principal investigator, Sapporo City General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052259
- Sponsor's protocol ID
- SPCR2009
- Status last verified
- Jan 2014
- First submitted
- 14 Jan 2010
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Cycling Treatment of Deoxyspergualin in Biopsy-proven Chronic Rejection of Kidney Transplantation
- ClinicalTrials.gov ID
- NCT01052259
- Acronym / sponsor ID
- SPCR2009
- Conditions
- Chronic Rejection
- Keywords
- Chronic rejection, Kidney, Transplantation, Immunosuppressive
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient patient enrollment
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nippon Kayaku Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Jan 2010 (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.
The purpose of this study to examine the efficacy and safety of cycling treatment of deoxyspergualin in renal transplant patients with biopsy-proven chronic rejection.
Detailed description
The primary aim of this study is to investigate the efficacy of deoxyspergualin after the completion of 6 cycles treatment. The efficacy valuables are histological findings in renal grafts, renal function, proteinuria, graft survival, anti-HLA antibody. The safety data are also evaluated in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deoxyspergualin, Treatment, | Experimental | Drug: Deoxyspergualin |
Who may qualify
- Ages
- 11 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic rejection defined by Banff 2007 criteria
Key exclusion criteria (3 listed)
- Patients who have recurrent renal diseases and virus-associated renal diseases
- Patients who have initial WBC < 4,000, neutrophil < 1,000 , platelet < 50,000 or Hb < 8g
- Patients who have acute or chronic infection
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 |
|---|---|---|
| DeoxyspergualinAlso: Spanidin, gusperimus hydrochloride100mg/vial as active substance; Deoxyspergualin at 3-5 mg/kg/day by 1-3 iv infusion will be given once a day for 5 to 7 days each cycle every month; Total cycle treatment will be 6. | Drug | Deoxyspergualin, Treatment, |
Primary outcome
Histopathological findings by Banff criteria
Time frame: 6 month after treatment initiation
1 secondary outcome
Renal function, proteinuria, graft survival, anti-HLA antibody, adverse events, serious adverse events (SAE)
Time frame: 6 and 12 months after treatment initiation
Results and safety
The study was stopped early (reason given: Insufficient patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
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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.
Hiroshi Harada, Chief principal investigator
Sapporo City General Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deoxyspergualin in people with Chronic Rejection, run by Nippon Kayaku Co., Ltd. at 8 sites 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
Are results available for this study?
The study was stopped early (reason given: Insufficient patient enrollment). Results are not available in the source record.
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?
Histopathological findings by Banff criteria (time frame: 6 month after treatment initiation). 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 8 Jan 2014.