End Stage Renal DiseasePhase 4NCT00784979
Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation
A Phase 4 study testing CMVIG in people with End Stage Renal Disease, run by Tampa General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to offer Panel Reactive Antibodies [PRA] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases: 1. Immunological Testing 2. Transplant Nephrectomy 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- CMVIG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Apr 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal transplant recipients with a potential living donor who is incompatible (T-\&/or B-cell locus) due to recipient high PRA or MHC antibodies
- PRA greater than or equal to 20% within last twelve months
- Recipient and donor accepted as potential candidates by the LifeLink Healthcare Renal Transplant Committee
Who cannot join
- Patients with known allergy to CytoGam(R), Cellcept, Rapamycin
- Patients who will receive IVIG or CytoGam(R) for any cause prior to protocol process
- ABO incompatibility
- Patients not capable of following through the treatment for various reasons as determined by treating physicians
- Any potential recipient who is pregnant or becomes pregnant
- Exclusion for Plasmapheresis: known allergy to ethylene oxide or natural rubber latex.
- Exclusion for Plasmapheresis: Intake of ACE-inhibitor or Angtiotensiin-receptor blockers in the last 24 hours prior to plasma exchange
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of PRA (Panel Reactive Antibody) in Sensitized Patients Awaiting Live-Donor Renal Transplantation
The purpose of this study is to offer Panel Reactive Antibodies [PRA] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases:
- Immunological Testing
- Transplant Nephrectomy
- Pharmacologic Therapy
- Plasmapheresis
- Transplant
Read the detailed description
Patients with high level of preformed antibodies (panel reactive antibodies [PRA]) to donor antigens make identification of a suitable donor difficult. For most transplant centers, 20-35% of patients waiting for a kidney transplant comprise this challenging group. These patients have a wait time of over five years and have many incompatible cross-matches with potential organ donors.
- Conditions
- End Stage Renal Disease
- Being tested
- CMVIG
- Keywords
- Renal, Transplant, PRA
- 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.
CMVIGDrug
Also called Cytomegalovirus Immune Globulin - Intravenous, Cytogam
400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks
| Study group | Role | What they receive |
|---|---|---|
| CMVIG followed by PP | No intervention | MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis Receives: Drug: CMVIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor
The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.
Measured: four weeks
Secondary outcomes (2)
Monitor Graft Survival
Measured: 5 years
Monitor Patient Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startJan 2002
- Primary completionDec 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampa General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Sponsor
- Investigators
- John Leone, MD, PhD, Principal investigator, Lifelink Healthcare Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784979
- Sponsor's protocol ID
- IIS_100109
- Status last verified
- Jun 2015
- First submitted
- 4 Nov 2008
- Last updated
- 29 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of PRA (Panel Reactive Antibody) in Sensitized Patients Awaiting Live-Donor Renal Transplantation
- ClinicalTrials.gov ID
- NCT00784979
- Acronym / sponsor ID
- IIS_100109
- Conditions
- End Stage Renal Disease
- Keywords
- Renal, Transplant, PRA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Tampa General HospitalUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- Jan 2002
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 5 Nov 2008 (estimated)
- Results
- Posted 29 Jun 2015
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 is to offer Panel Reactive Antibodies [PRA] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases:
- Immunological Testing
- Transplant Nephrectomy
- Pharmacologic Therapy
- Plasmapheresis
- Transplant
Detailed description
Patients with high level of preformed antibodies (panel reactive antibodies [PRA]) to donor antigens make identification of a suitable donor difficult. For most transplant centers, 20-35% of patients waiting for a kidney transplant comprise this challenging group. These patients have a wait time of over five years and have many incompatible cross-matches with potential organ donors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMVIG followed by PP | No intervention | Drug: CMVIGMMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Renal transplant recipients with a potential living donor who is incompatible (T-\&/or B-cell locus) due to recipient high PRA or MHC antibodies
- PRA greater than or equal to 20% within last twelve months
- Recipient and donor accepted as potential candidates by the LifeLink Healthcare Renal Transplant Committee
Key exclusion criteria (7 listed)
- Patients with known allergy to CytoGam(R), Cellcept, Rapamycin
- Patients who will receive IVIG or CytoGam(R) for any cause prior to protocol process
- ABO incompatibility
- Patients not capable of following through the treatment for various reasons as determined by treating physicians
- Any potential recipient who is pregnant or becomes pregnant
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 |
|---|---|---|
| CMVIGAlso: Cytomegalovirus Immune Globulin - Intravenous, Cytogam400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks | Drug | CMVIG followed by PP |
Primary outcome
The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor
Time frame: four weeks
The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.
2 secondary outcomes
Monitor Graft Survival
Time frame: 5 years
Monitor Patient Survival
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Tampa General Medical GroupLink 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.
John Leone, MD, PhD principal investigator
Lifelink Healthcare Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CMVIG in people with End Stage Renal Disease, run by Tampa General Hospital at 1 site 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 3 inclusion and 7 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 29 Jun 2015. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor (time frame: four 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 29 Jun 2015.