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Immunosuppressant
Abatacept Conversion for Kidney Transplant Recipients
Phase 2
Waitlist Available
Led By Idelberto R Badell, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult (age ≥18 years currently)
First-time renal transplant recipients of either living donor or deceased donors:
Must not have
Receiving belatacept at a dose other than 5 mg/kg body weight
Receiving mycophenolate mofetil at a dose of less than 1000 mg po QD (or mycophenolic acid or azathioprine equivalent).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post baseline, 24 months post baseline
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial is testing whether patients can safely switch from monthly IV infusions of belatacept to subcutaneous injections of abatacept without a decrease in kidney function.
Who is the study for?
This trial is for adults over 18 who've had their first kidney transplant from a living or deceased donor at least two years ago, are on specific immunosuppressants including belatacept, and have stable kidney function. They shouldn't have severe rejection history, active infections, significant proteinuria, uncontrolled diabetes, or be pregnant.
What is being tested?
The study compares monthly intravenous infusions of belatacept with subcutaneous injections of abatacept in maintaining kidney function post-transplant. It's a phase 2b trial to see if patients can switch between these treatments without harming their new kidney.
What are the potential side effects?
Potential side effects may include issues related to the immune system such as increased risk of infection, possible allergic reactions at injection sites for abatacept and infusion-related reactions for belatacept.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am receiving my first kidney transplant.
Select...
I have been treated with belatacept since my transplant.
Select...
This is my first organ transplant.
Select...
My immune system has low reactivity to certain transplant markers.
Select...
I have had only one major rejection episode after my transplant.
Select...
I am on specific immune-suppressing medications.
Select...
I had a transplant over 2 years ago and stopped CNI therapy more than 6 months ago.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking belatacept, but not at a 5 mg/kg dose.
Select...
I am taking less than 1000 mg of mycophenolate mofetil or its equivalent daily.
Select...
I have been taking more than 5 mg of prednisone daily in the last 3 months.
Select...
I have a high level of specific antibodies against a donor.
Select...
I've had more than one serious rejection episode after a transplant.
Select...
My kidney function is low (GFR below 35).
Select...
I am not on prednisone for long-term immune system suppression.
Select...
I have had more than one kidney transplant or received multiple organ transplants.
Select...
I have untreated latent tuberculosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post baseline, 24 months post baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post baseline, 24 months post baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in mean estimated GFR (eGFR) between randomization and 12 months post baseline
Secondary study objectives
Change in eGFR between abatacept and belatacept groups at 24 months
Compliance with patient-administered subcutaneous abatacept
First occurrence of graft loss or death post baseline
+13 moreSide effects data
From 2023 Phase 3 trial • 657 Patients • NCT0308634324%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
ACUTE RESPIRATORY FAILURE
12%
RASH
12%
WEIGHT INCREASED
12%
INFLUENZA
12%
FALL
12%
ARTHRALGIA
12%
URINARY TRACT INFECTION
12%
MUSCLE SPASMS
12%
SINUSITIS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
OROPHARYNGEAL PAIN
12%
LIVER FUNCTION TEST INCREASED
6%
PARAESTHESIA
6%
DEHYDRATION
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
SWELLING
6%
HYPONATRAEMIA
6%
CONSTIPATION
6%
RHEUMATOID ARTHRITIS
6%
RHINORRHOEA
6%
LEUKOCYTOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
ORAL CANDIDIASIS
6%
STAPHYLOCOCCAL INFECTION
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
FEELING HOT
6%
HEADACHE
6%
HAEMOGLOBIN DECREASED
6%
PHOTODERMATOSIS
6%
PATELLA FRACTURE
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
LIGAMENT RUPTURE
6%
PNEUMONIA BACTERIAL
6%
PERIPHERAL SWELLING
6%
FEMUR FRACTURE
6%
STOMATITIS
6%
SKIN LACERATION
6%
HYPOKALAEMIA
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHEST PAIN
6%
FATIGUE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CANDIDA INFECTION
6%
TACHYCARDIA
6%
COVID-19
6%
CATARACT
6%
SJOGREN'S SYNDROME
6%
DIZZINESS
6%
DYSPHAGIA
6%
INFECTIOUS PLEURAL EFFUSION
6%
OSTEOARTHRITIS
6%
ACUTE KIDNEY INJURY
6%
NAUSEA
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
OSTEOPENIA
6%
INSOMNIA
6%
PRURITUS
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
ERYTHEMA
6%
COSTOCHONDRITIS
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
6%
ASTHMA
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
SEBORRHOEIC KERATOSIS
6%
HEPATIC STEATOSIS
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
PHARYNGITIS
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
BACK PAIN
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/Upadacitinib 15 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/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
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Abatacept Group (Conversion Group)Experimental Treatment1 Intervention
Participants will receive the following:
* Abatacept 125 mg s.c. weekly
* Safety labs every 2 weeks (months 0-3) then monthly (months 4-12)
* Blood draws forPK atMonth 6, Month 12, and two random time points in between Month 6 and Month 12 for a total of four time points.
* Blood draws for PD studies at baseline/Month0 and Month 6 fora total of two timepoints.
* HLA labs at 6, 12 and 24 months
* Basic chemistry panel (CP Basic) at each study visit per clinical protocol for efficacy analysis
* Hemoglobin A1c at Screening visit
* Urine pregnancy test via test kit for WOCP at screening
* BK and CMV testing at 6, 12, and 24 months
Group II: Belatacept group (Control Group)Active Control1 Intervention
Participants will receive the following:
* Belatacept: 5 mg/kg i.v. monthly
* Blood draws for PD studies at baseline/Month 0 and Month 6 fora total of two timepoints.
* HLA labs at 6, 12 and 24 months
* Basic chemistry panel (CP Basic) every 3 months per clinical protocol for efficacy analysis
* Hemoglobin A1c at Screening visit
* Urine pregnancy test via test kit for WOCP at Screening visit
* BK and CMV testing at 6, 12, and 24 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
FDA approved
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,696 Previous Clinical Trials
2,603,604 Total Patients Enrolled
Idelberto R Badell, MDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking belatacept, but not at a 5 mg/kg dose.I am taking less than 1000 mg of mycophenolate mofetil or its equivalent daily.I have been taking more than 5 mg of prednisone daily in the last 3 months.I haven't had any organ rejection episodes in the last 6 months.I have had a CMV infection or virus presence in the last 3 months.I have a high level of specific antibodies against a donor.You have a history of substance abuse or a mental health condition that may make it difficult for you to follow the study instructions and attend follow-up appointments.I am 18 years old or older.I am receiving my first kidney transplant.I've had more than one serious rejection episode after a transplant.I have not taken antibiotics or antivirals in the last month.My kidney function is low (GFR below 35).I am not on prednisone for long-term immune system suppression.I have been treated with belatacept since my transplant.This is my first organ transplant.My immune system has low reactivity to certain transplant markers.I have had more than one kidney transplant or received multiple organ transplants.I have untreated latent tuberculosis.I have had only one major rejection episode after my transplant.I am on specific immune-suppressing medications.I had a transplant over 2 years ago and stopped CNI therapy more than 6 months ago.You have a low risk of immune system problems.
Research Study Groups:
This trial has the following groups:- Group 1: Abatacept Group (Conversion Group)
- Group 2: Belatacept group (Control Group)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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