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Biological

Abatacept for Kidney Transplant Recipients

Phase 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 months post-kidney transplant (post-kidney transplant)
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying 800 adult kidney transplant recipients to see if a biomarker can predict risk & if abatacept can improve outcomes.

Who is the study for?
This trial is for adult kidney transplant recipients who are on a stable medication regimen, have good kidney function (eGFRCKD-EPI 30-90 ml/min/1.73m^2) at 6 months post-transplant, and no acute rejection or significant infections. They must agree to use effective contraception and be able to consent. Exclusions include severe lung disease, certain viral infections like HIV or active hepatitis B, recent other vaccine or drug trials participation.
What is being tested?
The study first observes 800 patients to see if their HLA-DR/DQ mismatch score can predict immune system risk after a transplant. Then it randomly assigns 300 eligible patients either to continue standard care or switch from Tacrolimus to Abatacept treatment, monitoring kidney function improvement and quality of life for 18 months.
What are the potential side effects?
Abatacept may cause side effects such as infection risks due to immune system suppression, possible allergic reactions at the injection site since it's given subcutaneously (under the skin), and potentially increased risk of developing certain types of cancers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 months post-kidney transplant (post-kidney transplant)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 months post-kidney transplant (post-kidney transplant) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
In the Nested Randomized Control Trial (RCT) - Biopsy Proven Acute Rejection (BPAR) efficacy failure
In the Nested Randomized Control Trial (RCT) - Composite neurocognitive function (NIH-Toolbox Cognitive Battery) score
In the Observational Study - The occurrence of any alloimmune event

Side effects data

From 2023 Phase 3 trial • 657 Patients • NCT03086343
24%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
ACUTE RESPIRATORY FAILURE
12%
RASH
12%
INFLUENZA
12%
ARTHRALGIA
12%
URINARY TRACT INFECTION
12%
WEIGHT INCREASED
12%
FALL
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
LIVER FUNCTION TEST INCREASED
12%
OROPHARYNGEAL PAIN
6%
SEBORRHOEIC KERATOSIS
6%
HEADACHE
6%
NAUSEA
6%
HIP FRACTURE
6%
PHARYNGITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
HYPOKALAEMIA
6%
SJOGREN'S SYNDROME
6%
RHINORRHOEA
6%
PNEUMONIA BACTERIAL
6%
ASTHMA
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
CONSTIPATION
6%
HYPONATRAEMIA
6%
HEPATIC STEATOSIS
6%
DEHYDRATION
6%
PHOTODERMATOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
VOMITING
6%
PERIPHERAL SWELLING
6%
STAPHYLOCOCCAL INFECTION
6%
ORAL CANDIDIASIS
6%
HAEMOGLOBIN DECREASED
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
FEELING HOT
6%
COSTOCHONDRITIS
6%
LEUKOCYTOSIS
6%
TACHYCARDIA
6%
STOMATITIS
6%
PATELLA FRACTURE
6%
ACTINIC KERATOSIS
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CHEST PAIN
6%
FATIGUE
6%
CANDIDA INFECTION
6%
SKIN LACERATION
6%
COVID-19
6%
CATARACT
6%
INFECTIOUS PLEURAL EFFUSION
6%
DYSPHAGIA
6%
SWELLING
6%
ACUTE KIDNEY INJURY
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
OSTEOARTHRITIS
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
FEMUR FRACTURE
6%
LIGAMENT RUPTURE
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
INSOMNIA
6%
ERYTHEMA
6%
PRURITUS
6%
DERMATITIS ALLERGIC
6%
BACK PAIN
6%
DIZZINESS
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
OSTEOPENIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, Primary and 30 mg Cohorts: Abatacept
Period 1, Primary Cohort: Upadacitinib 15 mg QD

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Nested RCT - Treatment Group (Abatacept)Experimental Treatment1 Intervention
Eligible subjects will be re-consented and randomized to the investigational (abatacept/Mycophenolate mofetil (MMF)/Pred) Arm. Starting with abatacept at a fixed dose (125 mg s.c. weekly) and eliminate Calcineurin Inhibitor (CNI) over \~3 months using serial Tacrolimus (TAC) C0 level targets to taper the dose. 2200 subjects will be followed for 18 months post-randomization, monitoring for safety and improvement in renal function, neurocognitive function, and a life participation patient reported outcome measure (PROM). Subjects who develop Biopsy Proven Acute Rejection (BPAR) will have concurrent serum/urine/tissue samples collected and stored.
Group II: Nested RCT - Control Group (SOC)Active Control1 Intervention
Eligible subjects will be re-consented and randomized to the control group (tacrolimus/Mycophenolate mofetil (MMF)/Pred) . 100 subjects will be and followed for 18 months post-randomization, monitoring for safety and improvement in renal function, neurocognitive function, and a life participation patient reported outcome measure (PROM). Subjects who develop Biopsy Proven Acute Rejection (BPAR) will have concurrent serum/urine/tissue samples collected and stored.
Group III: Observational Study - Full CohortActive Control1 Intervention
800 adults first kidney transplant recipients will be followed observationally to evaluate HLA-DR/DQ molecular mismatch (mMM) as a risk-stratifying prognostic biomarker. Donor-recipient HLA-DR/DQ mMM score will be determined at enrollment and recipients will be followed over 24-months post-kidney transplant for primary alloimmune events (i.e., TCMR, DSA, and ABMR). Standard of care (SOC) therapy will be used to satisfy the FDA requirement to prospectively evaluate the HLA-DR/DQ mMM score as a prognostic biomarker for post-kidney transplant outcomes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
2005
Completed Phase 4
~112250

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,382,034 Total Patients Enrolled
Peter Nickerson, M.D.Study ChairUniversity of Manitoba Max Rady College of Medicine - Transplantation
Peter S Heeger, M.D.Study ChairCedars Sinai Medical Center: Transplantation
1 Previous Clinical Trials
178 Total Patients Enrolled

Media Library

Abatacept (Biological) Clinical Trial Eligibility Overview. Trial Name: NCT05917522 — Phase 2
Kidney Transplant Research Study Groups: Nested RCT - Control Group (SOC), Nested RCT - Treatment Group (Abatacept), Observational Study - Full Cohort
Kidney Transplant Clinical Trial 2023: Abatacept Highlights & Side Effects. Trial Name: NCT05917522 — Phase 2
Abatacept (Biological) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05917522 — Phase 2
~533 spots leftby Jul 2027
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