Renal TransplantationNCT00719225
A Belatacept Compassionate Use Study for Patients With a Kidney Transplant
A study testing Belatacept in people with Renal Transplantation, run by Bristol-Myers Squibb at 7 sites in United States.
Trial summary
To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either: unable to construct an adequate immunosuppression regimen due to nonrenal toxicity / contraindication (and withdrawing the causative agent would… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Belatacept
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 7 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Men and women of age 18 years or older inclusive
- Recipient of a renal allograft for at least ≥ 2 months
- EBV positive
- Unable to tolerate a suitable immunosuppression regimen to prevent acute allograft rejection, due to:
- Extra-renal toxicity related to CNIs and/or m-TOR inhibitors that is refractory to medical management (eg, uncontrolled seizures)
- Contraindication to CNIs and/or m-TOR inhibitors
Show all 11Show fewer
- OR
- At imminent risk of losing allograft kidney due to nephrotoxicity
- Renal failure: ≥ Stage 4 on KDOQI Scale (GFR 15 - 29 cc/min)
- And no other renal replacement therapy
- Subjects must be receiving the maintenance immunosuppressants MMF, MPA, or AZA
Who cannot join
- Any significant infection, extra-renal solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplants, with an unresolved episode of AR within the last 6 weeks
- EBV negative
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The Transplant Center Of The Lehigh Valley
Allentown, Pennsylvania, 18103
Office Of Dr. Allan Kirk
Atlanta, Georgia, 30322
UNC Kidney Center
Chapel Hill, North Carolina, 27514
Scripps Green Hospital
La Jolla, California, 92037
Acadiana Renal Physicians
New Iberia, Louisiana, 70563
Tulane Abdominal Transplant Institute
New Orleans, Louisiana, 70112
Texas Transplant Physician'S Group
San Antonio, Texas, 78229
About this study
Official title: Belatacept for Renal Allograft Recipients: A Compassionate Use Program
To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either:
- unable to construct an adequate immunosuppression regimen due to nonrenal toxicity / contraindication (and withdrawing the causative agent would lead to renal graft loss) OR
- at imminent risk of losing the allograft kidney due to nephrotoxicity and have no other options for renal replacement therapy
- Conditions
- Renal Transplantation
- Being tested
- Belatacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelataceptDrug
Also called LEA29Y, BMS-224818
IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719225
- Sponsor's protocol ID
- IM103-056
- Status last verified
- Nov 2021
- First submitted
- 17 Jul 2008
- Last updated
- 23 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belatacept for Renal Allograft Recipients: A Compassionate Use Program
- ClinicalTrials.gov ID
- NCT00719225
- Acronym / sponsor ID
- IM103-056
- Conditions
- Renal Transplantation
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- First posted
- 21 Jul 2008 (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.
To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either:
- unable to construct an adequate immunosuppression regimen due to nonrenal toxicity / contraindication (and withdrawing the causative agent would lead to renal graft loss) OR
- at imminent risk of losing the allograft kidney due to nephrotoxicity and have no other options for renal replacement therapy
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women of age 18 years or older inclusive
- Recipient of a renal allograft for at least ≥ 2 months
- EBV positive
- Unable to tolerate a suitable immunosuppression regimen to prevent acute allograft rejection, due to:
- Extra-renal toxicity related to CNIs and/or m-TOR inhibitors that is refractory to medical management (eg, uncontrolled seizures)
Key exclusion criteria (2 listed)
- Any significant infection, extra-renal solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplants, with an unresolved episode of AR within the last 6 weeks
- EBV negative
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 |
|---|---|---|
| BelataceptAlso: LEA29Y, BMS-224818IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Belatacept in people with Renal Transplantation, run by Bristol-Myers Squibb at 7 sites in United States.
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 11 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
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.
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 23 Nov 2021.