End Stage Renal DiseasePhase 4BelatPilotNCT02130817

Belatacept in Kidney Transplantation of Moderately Sensitized Patients

A Phase 4 study testing Belatacept, Tacrolimus withdrawal and Plasmapheresis/Intravenous Immunoglobulin G in people with End Stage Renal Disease and Antibody Mediated Rejection, run by University of Wisconsin, Madison at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: End Stage Renal Disease, Antibody Mediated Rejection
What is being tested?: Belatacept, Tacrolimus withdrawal and Plasmapheresis/Intravenous Immunoglobulin G
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 24 Sep 2014to 9 Oct 2015
Phase: Phase 4
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects 18-70 years of age
Patient who is receiving an expanded criteria donor (ECD) or deceased cardiac donor (DCD) kidney
Have immunodominant donor specific antibodies (DSA) 1,000 - 4,000 mean fluorescent intensity (MFI) by single bead Luminex bioassay
Subjects must be capable of understanding the investigational nature and risks of the study and must sign a statement of informed consent
Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion and be willing to use contraceptives for the duration of the study and for 8 weeks after the last dose of study drug Women of Child-Bearing Potential (WOCBP) includes
Women who have experienced menarche and who have not undergone successful surgical sterilization or who are not post-menopausal

Show all 12Show fewer

Women using oral contraceptives, other hormonal contraceptives, or mechanical products such as intrauterine devices or barrier methods
Women who are practicing abstinence
Women who have a partner who is sterile (eg, due to vasectomy).
Women must not be breast-feeding
Male subjects must agree to use an acceptable method for contraception for the duration of the study
Patient must have known positive Epstein-Barr virus (EBV) serostatus

Who cannot join

Patient has previously received an organ transplant other than a kidney.
Patient is receiving an human leukocyte antigen (HLA) identical living donor transplant
Patient who is a recipient of a multiple organ transplant
Patient with a positive T or B cell crossmatch
Patient with a donor specific antibody (DSA) as deemed by the local PI to be associated with significant risk of rejection
Patient has received an ABO incompatible donor kidney

Show all 26Show fewer

Recipients will be receiving a dual or en bloc kidney transplant
Donor anticipated cold ischemia is > 30hours
Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus (HBV) except for hepatitis B surface antibody positive. HCV seropositive patients with a negative HCV viral load testing may be included.
Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
Seronegative or unknown EBV serostatus
Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
Patients with tuberculosis who have not been treated for latent infection.
Patients at high risk for polyoma virus-associated nephropathy, which is mostly due to BK virus infection
Patients at high risk for polyoma virus-associated nephropathy, which is mostly due to BK virus infection
Patients with thrombocytopenia (PLT <75,000/mm3), and/or leucopoenia (WBC < 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
Patient is taking or has been taking an investigational drug in the 30 days prior to transplant
Patient who has undergone desensitization therapy within 6 months prior to transplant
Patient has a known hypersensitivity to belatacept, tacrolimus, mycophenolate mofetil, alemtuzumab, rabbit anti-thymocyte globulin, or glucocorticoids
Patient is receiving chronic steroid therapy at the time of transplant
Patients with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years
Patients with > Grade 2 peripheral neuropathy within 14 days before enrollment
Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiography evidence of acute ischemia or active conduction system abnormalities.
Female subject is pregnant or breast-feeding
Serious medical or psychiatric illness likely to interfere with participation in this clinical study. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
Prisoners or subjects who are involuntarily incarcerated

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wiscsonsin Hospital and Clinics
Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Belatacept for the Management of Moderately Sensitized Patients at Risk for Delayed Graft Function (DGF)

The purpose of this study is to evaluate the safety and effectiveness of an immunosuppressive medication, Belatacept, as a replacement for a calcineurin inhibitor, in combination with a standard of care regimen of immunosuppressive medications and plasma exchange (plasmapheresis and immunoglobulin treatment) for kidney transplant patients who are moderately sensitized against their deceased donor and at-risk for delayed graft function. The hypothesis is that moderately sensitized patients who receive Belatacept treatment with the standard of care regimen will lead to lower acute rejection rates than historical controls based on assessment of standard of care biopsies and standard Banff criteria.

Read the detailed description

This exploratory single-center, open-label safety and efficacy study will enroll 20 adult kidney transplants candidates, moderately sensitized against their deceased donor and at-risk for delayed graft function (DGF), to receive Belatacept (days 0,5, weeks 2,4,8 and 12 (10 mg/kg), and every 4 weeks thereafter (5 mg/kg)), plasma exchange (once before and twice after transplant) and Intravenous Immunoglobulin (IVIG) (100 mg/kg after each plasma exchange), along with Thymoglobulin (ATG) induction and Dexamethasone tapered dosing starting on the day of transplant at 100mg IV, tapered through Day 4, followed by prednisone at 30 mg on Day 5 with tapered dosing to prednisone 10 mg/d by one month, with a total observation period of 1 year. Patients will be tapered off tacrolimus by week 8 and will remain on mycophenolic acid and prednisone for the total length of the study. Subjects will be followed until 1 year post transplant.

Conditions: End Stage Renal Disease, Antibody Mediated Rejection
Being tested: Belatacept, Tacrolimus withdrawal, Plasmapheresis/Intravenous Immunoglobulin G, Thymoglobulin (ATG), Myfortic
Keywords: Renal Transplant, Kidney Transplant, Mean flourescent Intensity, Delayed Graft Function, Antagonist of Thymocyte Cell Activation
Medical subject headings: Kidney Failure, Chronic, Delayed Graft Function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BelataceptDrug
Also called Nujolix
Belatacept will be added to the standard of care regimen and will be given at days 0,5, weeks 2, 4, 8 and 12 (10 mg/kg) and every 4 weeks (5 mg/kg) for one year.
Tacrolimus withdrawalDrug
Tacrolimus dosing will begin on Days 1 through 5 post transplant at up to 2 mg BID to achieve target trough levels of 9-11 ng/ml. The dose will be tapered through the end of week 2 to achieve a trough level of 4 ng/ml which will be maintained for six weeks. Tacrolimus will be withdrawn at the end of eight weeks post transplant.
Plasmapheresis/Intravenous Immunoglobulin GProcedure or surgery
Enrolled patients will start with standard of practice treatment including plasmapheresis and IVIG therapy twice after transplant, on days 2 and 4 and potentially once before transplant. Plasmapheresis and albumin exchange for one volume of blood will be performed in the infusion center at the University of Wisconsin Hospital and Clinics (UWHC). Each pheresis session will be completed by IVIG infusion. While plasmapheresis will help with the removal of circulating Donor Specific Antibodies (DSA), IVIG therapy will provide immunomodulatory characteristics that include sterilizing immunity from infections, inhibiting and scavenging activated complement fragments, modifying cell-mediated immune responses, inducing regulatory T cells and importantly, inhibiting deleterious antibody production.
Thymoglobulin (ATG)Drug
Also called Anti-thymocyte globulin
Thymoglobulin (ATG) Induction. Thymoglobulin will be administered to a total cumulative dose of 4.5-6 mg/kg via a peripheral or central vein, starting in the operating room.
MyforticDrug
Patients will receive 720mg bid of Myfortic throughout the study, starting day 1 after surgery.
SteroidsDrug
Also called Dexamethasone, Prednisone
Patients will receive Dexamethasone IV on the day of surgery (Day 0) with tapered doses through Day 4 followed by prednisone tapered to 10mg/d by day 30.,

Study groups in NCT02130817
Study group	Role	What they receive
Belatacept	Experimental	Belatacept (nujolix): Tacrolimus withdrawal Standard of care(SOC) treatment: Plasmapheresis/Intravenous Immunoglobulin G (IVIG) therapy Thymoglobulin will be administered to a total cumulative dose of 4.5-6 mg/kg starting in the operating room. Maintenance immunosuppression: Myfortic: Patients will receive 720mg bid of Myfortic throughout the study, starting day 1 after surgery. Steroids: Patients will receive Dexamethasone IV on the day of surgery (Day 0) with tapered doses through Day 4 followed by prednisone tapered to 10mg/d by day 30. Receives: Drug: Belatacept; Drug: Tacrolimus withdrawal; Procedure: Plasmapheresis/Intravenous Immunoglobulin G; Drug: Thymoglobulin (ATG); Drug: Myfortic; Drug: Steroids

What is being measured

The primary outcome is the main question the study is designed to answer.

Acute rejection
Acute rejection rates are based on assessment of standard of care biopsy (protocol and indication) and standard Banff criteria.
Measured: one year

Secondary outcomes (6)

Patient and Graft Survival
The number of subjects alive and with functioning grafts at one year.
Measured: One year
Incidence of infections
Number of subjects in the study who have developed infections, including cytomegalovirus (CMV) and BK Virus, in the first year post-transplant
Measured: One year
Incidence of de novo donor specific antibody (DSA)
Number of subjects who have developed donor specific antibodies at one year post transplant.
Measured: One year
Incidence of new onset diabetes
Number of subjects in the study who have developed new onset diabetes since receiving the transplant
Measured: One year
Increase in estimated Glomerular Filtration Rate (eGFR)
Number of subjects in the study whose eGFR has decreased to < 45 milliliters/ minute
Measured: One year
Incidence of malignancies
Number of subjects in the study who have developed malignancies including post-transplant lymphoproliferative (PTLD) disorder
Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 20149 Oct 2015

First posted5 May 2014 (estimated)
Study start24 Sep 2014
Primary completion9 Oct 2015
Study completion9 Oct 2015

Why it stopped: Organ transplant criteria made recruitment difficult. Closed with IRB 10/09/2015.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02130817
Sponsor's protocol ID: Should be 2013-0672
Other IDs: IM103-327
Acronym: BelatPilot
Status last verified: Dec 2018
First submitted: 30 Apr 2014
Last updated: 17 Dec 2018
Results posted: No
Data monitoring committee: Yes

Publications

Trivedi HL, Terasaki PI, Feroz A, Everly MJ, Vanikar AV, Shankar V, Trivedi VB, Kaneku H, Idica AK, Modi PR, Khemchandani SI, Dave SD. Abrogation of anti-HLA antibodies via proteasome inhibition. Transplantation. 2009 May 27;87(10):1555-61. doi: 10.1097/TP.0b013e3181a4b91b.
PubMed 19461494
Jordan SC, Pescovitz MD. Presensitization: the problem and its management. Clin J Am Soc Nephrol. 2006 May;1(3):421-32. doi: 10.2215/CJN.01651105. Epub 2006 Apr 12.
PubMed 17699241
Stegall MD, Gloor J, Winters JL, Moore SB, Degoey S. A comparison of plasmapheresis versus high-dose IVIG desensitization in renal allograft recipients with high levels of donor specific alloantibody. Am J Transplant. 2006 Feb;6(2):346-51. doi: 10.1111/j.1600-6143.2005.01178.x.
PubMed 16426319
Vo AA, Lukovsky M, Toyoda M, Wang J, Reinsmoen NL, Lai CH, Peng A, Villicana R, Jordan SC. Rituximab and intravenous immune globulin for desensitization during renal transplantation. N Engl J Med. 2008 Jul 17;359(3):242-51. doi: 10.1056/NEJMoa0707894.
PubMed 18635429
Montgomery RA, Zachary AA. Transplanting patients with a positive donor-specific crossmatch: a single center's perspective. Pediatr Transplant. 2004 Dec;8(6):535-42. doi: 10.1111/j.1399-3046.2004.00214.x.
PubMed 15598320
Magee CC, Felgueiras J, Tinckam K, Malek S, Mah H, Tullius S. Renal transplantation in patients with positive lymphocytotoxicity crossmatches: one center's experience. Transplantation. 2008 Jul 15;86(1):96-103. doi: 10.1097/TP.0b013e318176ae2c.
PubMed 18622284
Thielke JJ, West-Thielke PM, Herren HL, Bareato U, Ommert T, Vidanovic V, Campbell-Lee SA, Tzvetanov IG, Sankary HN, Kaplan B, Benedetti E, Oberholzer J. Living donor kidney transplantation across positive crossmatch: the University of Illinois at Chicago experience. Transplantation. 2009 Jan 27;87(2):268-73. doi: 10.1097/TP.0b013e3181919a16.
PubMed 19155983
Jordan SC, Toyoda M, Vo AA. Intravenous immunoglobulin a natural regulator of immunity and inflammation. Transplantation. 2009 Jul 15;88(1):1-6. doi: 10.1097/TP.0b013e3181a9e89a.
PubMed 19584672
Investigator Brochure. Belatacept (BMS-2224818), Version 13. Bristol-Myers Squibb Research and Development Department. 15 December 2010.
U.S. Prescribing information for Nulojix® (belatacept), Revised 06/2011. Bristol-Myers Squibb.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Belatacept for the Management of Moderately Sensitized Patients at Risk for Delayed Graft Function (DGF)
ClinicalTrials.gov ID: NCT02130817
Acronym / sponsor ID: BelatPilot / Should be 2013-0672
Conditions: End Stage Renal Disease, Antibody Mediated Rejection
Keywords: Renal Transplant, Kidney Transplant, Mean flourescent Intensity, Delayed Graft Function, Antagonist of Thymocyte Cell Activation
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Organ transplant criteria made recruitment difficult. Closed with IRB 10/09/2015.
Enrolment: 0 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: Bristol-Myers Squibb
Study start: 24 Sep 2014 (actual)
Primary completion: 9 Oct 2015 (actual)
Study completion: 9 Oct 2015 (actual)
First posted: 5 May 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Belatacept	Experimental	Drug: Belatacept, Drug: Tacrolimus withdrawal, Procedure: Plasmapheresis/Intravenous Immunoglobulin G, Drug: Thymoglobulin (ATG), Drug: Myfortic, Drug: SteroidsBelatacept (nujolix): Tacrolimus withdrawal Standard of care(SOC) treatment: Plasmapheresis/Intravenous Immunoglobulin G (IVIG) therapy Thymoglobulin will be administered to a total cumulative dose of 4.5-6 mg/kg starting in the operating room. Maintenance immunosuppression: Myfortic: Patients will receive 720mg bid of Myfortic throughout the study, starting day 1 after surgery. Steroids: Patients will receive Dexamethasone IV on the day of surgery (Day 0) with tapered doses through Day 4 followed by prednisone tapered to 10mg/d by day 30.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Male or female subjects 18-70 years of age
Patient who is receiving an expanded criteria donor (ECD) or deceased cardiac donor (DCD) kidney
Have immunodominant donor specific antibodies (DSA) 1,000 - 4,000 mean fluorescent intensity (MFI) by single bead Luminex bioassay
Subjects must be capable of understanding the investigational nature and risks of the study and must sign a statement of informed consent
Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion and be willing to use contraceptives for the duration of the study and for 8 weeks after the last dose of study drug Women of Child-Bearing Potential (WOCBP) includes

Key exclusion criteria (26 listed)

Patient has previously received an organ transplant other than a kidney.
Patient is receiving an human leukocyte antigen (HLA) identical living donor transplant
Patient who is a recipient of a multiple organ transplant
Patient with a positive T or B cell crossmatch
Patient with a donor specific antibody (DSA) as deemed by the local PI to be associated with significant risk of rejection

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: NujolixBelatacept will be added to the standard of care regimen and will be given at days 0,5, weeks 2, 4, 8 and 12 (10 mg/kg) and every 4 weeks (5 mg/kg) for one year.	Drug	Belatacept
Tacrolimus withdrawalTacrolimus dosing will begin on Days 1 through 5 post transplant at up to 2 mg BID to achieve target trough levels of 9-11 ng/ml. The dose will be tapered through the end of week 2 to achieve a trough level of 4 ng/ml which will be maintained for six weeks. Tacrolimus will be withdrawn at the end of eight weeks post transplant.	Drug	Belatacept
Plasmapheresis/Intravenous Immunoglobulin GEnrolled patients will start with standard of practice treatment including plasmapheresis and IVIG therapy twice after transplant, on days 2 and 4 and potentially once before transplant. Plasmapheresis and albumin exchange for one volume of blood will be performed in the infusion center at the University of Wisconsin Hospital and Clinics (UWHC). Each pheresis session will be completed by IVIG infusion. While plasmapheresis will help with the removal of circulating Donor Specific Antibodies (DSA), IVIG therapy will provide immunomodulatory characteristics that include sterilizing immunity from infections, inhibiting and scavenging activated complement fragments, modifying cell-mediated immune responses, inducing regulatory T cells and importantly, inhibiting deleterious antibody production.	Procedure or surgery	Belatacept
Thymoglobulin (ATG)Also: Anti-thymocyte globulinThymoglobulin (ATG) Induction. Thymoglobulin will be administered to a total cumulative dose of 4.5-6 mg/kg via a peripheral or central vein, starting in the operating room.	Drug	Belatacept
MyforticPatients will receive 720mg bid of Myfortic throughout the study, starting day 1 after surgery.	Drug	Belatacept
SteroidsAlso: Dexamethasone, PrednisonePatients will receive Dexamethasone IV on the day of surgery (Day 0) with tapered doses through Day 4 followed by prednisone tapered to 10mg/d by day 30.,	Drug	Belatacept

Primary outcome

Acute rejection
Time frame: one year
Acute rejection rates are based on assessment of standard of care biopsy (protocol and indication) and standard Banff criteria.

6 secondary outcomes

Patient and Graft Survival
Time frame: One year
Incidence of infections
Time frame: One year
Incidence of de novo donor specific antibody (DSA)
Time frame: One year
Incidence of new onset diabetes
Time frame: One year
Increase in estimated Glomerular Filtration Rate (eGFR)
Time frame: One year
Incidence of malignancies
Time frame: One year

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
Background: PubMed 19461494Trivedi HL, Terasaki PI, Feroz A, Everly MJ, Vanikar AV, Shankar V, Trivedi VB, Kaneku H, Idica AK, Modi PR, Khemchandani SI, Dave SD. Abrogation of anti-HLA antibodies via proteasome inhibition. Transplantation. 2009 May 27;87(10):1555-61. doi: 10.1097/TP.0b013e3181a4b91b.
Background: PubMed 17699241Jordan SC, Pescovitz MD. Presensitization: the problem and its management. Clin J Am Soc Nephrol. 2006 May;1(3):421-32. doi: 10.2215/CJN.01651105. Epub 2006 Apr 12.
Background: PubMed 16426319Stegall MD, Gloor J, Winters JL, Moore SB, Degoey S. A comparison of plasmapheresis versus high-dose IVIG desensitization in renal allograft recipients with high levels of donor specific alloantibody. Am J Transplant. 2006 Feb;6(2):346-51. doi: 10.1111/j.1600-6143.2005.01178.x.
Background: PubMed 18635429Vo AA, Lukovsky M, Toyoda M, Wang J, Reinsmoen NL, Lai CH, Peng A, Villicana R, Jordan SC. Rituximab and intravenous immune globulin for desensitization during renal transplantation. N Engl J Med. 2008 Jul 17;359(3):242-51. doi: 10.1056/NEJMoa0707894.
Background: PubMed 15598320Montgomery RA, Zachary AA. Transplanting patients with a positive donor-specific crossmatch: a single center's perspective. Pediatr Transplant. 2004 Dec;8(6):535-42. doi: 10.1111/j.1399-3046.2004.00214.x.
Background: PubMed 18622284Magee CC, Felgueiras J, Tinckam K, Malek S, Mah H, Tullius S. Renal transplantation in patients with positive lymphocytotoxicity crossmatches: one center's experience. Transplantation. 2008 Jul 15;86(1):96-103. doi: 10.1097/TP.0b013e318176ae2c.
Background: PubMed 19155983Thielke JJ, West-Thielke PM, Herren HL, Bareato U, Ommert T, Vidanovic V, Campbell-Lee SA, Tzvetanov IG, Sankary HN, Kaplan B, Benedetti E, Oberholzer J. Living donor kidney transplantation across positive crossmatch: the University of Illinois at Chicago experience. Transplantation. 2009 Jan 27;87(2):268-73. doi: 10.1097/TP.0b013e3181919a16.
Background: PubMed 19584672Jordan SC, Toyoda M, Vo AA. Intravenous immunoglobulin a natural regulator of immunity and inflammation. Transplantation. 2009 Jul 15;88(1):1-6. doi: 10.1097/TP.0b013e3181a9e89a.
BackgroundInvestigator Brochure. Belatacept (BMS-2224818), Version 13. Bristol-Myers Squibb Research and Development Department. 15 December 2010.
BackgroundU.S. Prescribing information for Nulojix® (belatacept), Revised 06/2011. Bristol-Myers Squibb.

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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.

Arjang Djamali, M.D. principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 26 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: withdrawn, as of the sponsor's last update on 17 Dec 2018. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Acute rejection (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02130817, which also lists 10 linked publications.

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 17 Dec 2018.