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New treatment option for Kidney Transplant
Official title Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation
ClinicalTrials.gov ID: NCT05917522
What this study is testing
What is Abatacept?
Abatacept is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for kidney transplant.
Also referred to as Orencia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 800 adult first time kidney transplant recipients will be enrolled in the Observational Study and followed to evaluate their Human Leukocyte Antigen (HLA)-DR/DQ molecular mismatch (mMM) score as a risk-stratifying prognostic biomarker. Six months after transplant the study will identify those who meet the eligibility criteria for the Nested Randomized Control Trial (RCT).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Observational Study:
- Subject must be able to understand and provide informed consent
- Received (within 14 days) or candidate for an ABO-compatible kidney transplant, including A2 to B
- Panel Reactive Antibody \<=60% as determined by local site
- Virtual cross-match negative as determined by local site or Donor Specific Antibody (DSA) negative by central lab within 14 days post-transplant
You likely can't join if
- Observational Study:
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol including a mandated 6-mo kidney...
- Non-Kidney Transplant (KTx) (pre-existing or concurrent)
- Current use of immunomodulatory agents (including but not limited to: Rituximab, anti-Tumor necrosis factor(TNF) Monoclonal antibodies (mAb), or...
- Transplant in which the kidney donor is the recipient's Identical twin
- Epstein-Barr virus (EBV) sero-negative KTx recipient
See the full eligibility criteria
Who can join
- Observational Study:
- Subject must be able to understand and provide informed consent
- Received (within 14 days) or candidate for an ABO-compatible kidney transplant, including A2 to B
- Panel Reactive Antibody \<=60% as determined by local site
- Virtual cross-match negative as determined by local site or Donor Specific Antibody (DSA) negative by central lab within 14 days post-transplant
- Female people of childbearing potential must have a negative pregnancy test upon study entry
- All people with reproductive potential must agree to use highly effective contraception for the duration of the study (http://www.fda.gov/birthcontrol)
- Hepatitis C Virus Ab positive people with negative Hepatitis C Virus polymerase chain reaction (HCV PCR) are eligible if they have spontaneously cleared infection or are in sustained virologic remission
- Vaccines up to date as per Division of Allergy, Immunology, and Transplantation (DAIT) guidance for patients in transplant trials (Refer to Manual of Procedures).
- Triple Immunosuppression - Calcineurin Inhibitor/Mycophenolic Acid/Steroid (CNI/MPA/steroid)
- CNI (Tacrolimus (TAC), target trough [C0] level: 0-3 mo, 8-12 ng/mL; 4-6 mo, 6-10 ng/mL; \>6 mo, 5-8 ng/mL])
- MPA [target dose: mycophenolate mofetil \>=500 mg bid or mycophenolate sodium \>=360 mg bid]); and
- Glucocorticoid, with a minimum dose equivalent to 5mg of prednisone per day Nested assigned by chance Control Trial (RCT):
- Subject must be able to understand and provide informed consent
- A 6-month protocol biopsy free of Biopsy Proven Acute Rejection (BPAR)(by Central Pathology Core)
- Negative 6-month serum test for DSA (by Central HLA Core)
- eGFRCKD-EPI 30-90 ml/min/1.73m\^2 at 6 months
- Has a verified negative purified protein derivative (PPD) or negative testing for tuberculosis using an approved IGRA blood test, such as QuantiFERON Gold TB or T-SPOT-TB assay OR has completed treatment for latent...
- Minimum Mycophenolate mofetil (MPA) dose (MPA 500 mg po bid, or Mycophenolate sodium 360 mg po bid)
- Minimum Prednisone dose of 5mg per day
- Hepatitis C Virus Ab positive people with negative HCV PCR are eligible if they have spontaneously cleared infection or are in sustained virologic remission
- Hepatitis C Virus negative recipients of a Hepatitis C Virus positive organ are eligible if they have undergone treatment and are in sustained virologic remission
- Female people of childbearing potential must have a negative pregnancy test upon study entry
- All people with reproductive potential, must agree to use highly effective contraception the duration of the study-specific methods may be listed, if applicable
What rules you out
- Observational Study:
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol including a mandated 6-mo kidney transplant biopsy
- Non-Kidney Transplant (KTx) (pre-existing or concurrent)
- Current use of immunomodulatory agents (including but not limited to: Rituximab, anti-Tumor necrosis factor(TNF) Monoclonal antibodies (mAb), or Belatacept, abatacept, Janus kinase inhibitors)
- Transplant in which the kidney donor is the recipient's Identical twin
- Epstein-Barr virus (EBV) sero-negative KTx recipient
- Chronic obstructive pulmonary disease (COPD)
- Untreated Latent Tuberculosis (TB)
- Human immunodeficiency virus (HIV) infection
- Active Hepatitis B infection (HBsAg+ or anti-HBcore +)
- Enrollment in another investigational trial
- Current, diagnosed, mental illness or current, diagnosed or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
- Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment
- Use of investigational drugs within 8 weeks of participation
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
- Use of Campath(R) Nested assigned by chance Control Trial (RCT):
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Biopsy Proven Acute Rejection (BPAR) or treated clinically-diagnosed rejection in the 6 months following enrollment in the Observational Study
- Positive for a Donor Specific Antibody (DSA) 0-6 months post-kidney transplant
- Acute Banff interstitial (i) score \>0 on a 6-month protocol biopsy as determined by core pathology read
- Presence of recurrent on de novo glomerulonephropathy 0-6 months post-kidney transplant
- Presence of active infection including BK virus (BKV), Cytomegalovirus (CMV) or EBV viremia by Polymerase chain reaction (PCR) analysis
- Unable or unwilling to undergo protocol biopsies
- Not on Tacrolimus/Mycophenolic Acid (MPA)/Pred
- Unable to administer therapy s.c.
- Thrombocytopenia (\<50,000/mm\^3)
- Pregnant, or unwilling to practice highly effective birth control
- Use of immunomodulatory agents (including but not limited to Rituximab, anti-TNF mAb, or Belatacept, abatacept, Janus kinase inhibitors) \ since enrollment, other than cytolytic agents (i.e., Thymoglobulin(R)or...
- Use of investigational drugs since transplant
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- New Haven, Connecticut, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Charlottesville, Virginia, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; New Haven, Connecticut, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.