Belatacept Immunosuppression Therapy in Post-Transplant Kidney Recipients: Comparison of 4-Week and 8-Week Dosing Intervals
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline
研究概览
简要总结
The purpose of this study is to transition patients who have been stable on Belatacept for one year after kidney transplant from standard 4-week to an investigational 8-week belatacept dosing schedule. The investigators hypothesize that renal function and acute rejection rates will be non-inferior with 8-week belatacept dosing.
详细描述
The current dosing protocol for patients who have undergone a kidney transplant requires that Belatacept be given as an infusion every 4 weeks. The investigator wants to assess if the patients who have been stable for one year after transplant can be safely transitioned to an 8-week Belatacept infusion schedule. Renal function and any episodes of acute rejection will be closely monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age ≥18 years currently),
- •First-time renal transplant recipients of either living donor or deceased donor,
- •who were initiated on belatacept at the time of transplant and
- •are at least one year post-transplant and off CNI therapy for at least 6 months.
- •Patients at low immunologic risk, defined as
- •patients with a first transplant who have a PRA < 50 against class I and class II antigens,
- •no DSA (donor-specific antibodies),
- •who have not had more than one episode of rejection, and
- •no episodes of rejection within the last 6 months prior to enrollment, and
- •no rejection with a grade of IIB or above.
排除标准
- •Not first renal transplant, or multi-organ transplant recipient
- •History of greater than one episode of biopsy-proven acute rejection, or of rejection of Banff 97 grade IIB or greater, or rejection within the last 6 months.
- •Pregnancy (women of childbearing potential must use adequate contraception during study)
- •Unwilling to receive all belatacept infusions at the Emory Transplant Center
- •Calculated Glomerular Filtration Rate (GFR) less than
- •Serum creatinine at enrollment over 30% higher than 3 months (±4 weeks) prior to randomization
- •HbA1C greater than 8 at enrollment
- •Recent history of significant proteinuria (protein/Cr ratio >1)
- •Non-standard belatacept dosing (e.g. dose other than 5 mg belatacept/kg body weight)
- •Cellcept dose less than 500 mg po bid.
- •Prednisone dose greater than 5mg po qd within 3 months of randomization
- •Patients not currently taking prednisone
- •Active infection, or antibiotic or antiviral drug therapy within 1 month of randomization
- •Evidence of Cytomegalovirus (CMV) viremia or clinical CMV infection within last 3 months.
- •Polyomavirus BK PCR (polymerase chain reaction) load greater then 4.3 (copy number greater than 20,0000) within 3 months of randomization
- •Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing not required)
- •Known HIV (human immunodeficiency virus infection) (testing not required)
- •Presence of donor specific antibody by Luminex single antigen assessment, or panel reactivity (PRA) above 50%.
- •History of substance abuse or psychiatric disorder not compatible with study adherence and follow up.
研究组 & 干预措施
Belatacept 8-weekly
Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks.
干预措施: Belatacept (Drug)
Belatacept 4-weekly
Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks.
干预措施: Belatacept (Drug)
结局指标
主要结局
Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline
时间窗: 12 months from baseline
The mean estimated Glomerular Filtration Rate (eGFR) will be calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using serum creatinine measurements and the patient's age, gender, and race. An eGFR below 60 ml/min/1.73 m\^2 indicates lower renal function.
次要结局
- Number of Participants With Transplant Rejection at 6 Months and 12 Months Post Baseline(6 months post baseline, 12 months post baseline)
- Number of Deaths at 6 Months and 12 Months Post Baseline(6 months post baseline, 12 months post baseline)
- Number of Subjects That Experienced Graft Loss at 6 Moths and 12 Months Post Baseline(6 months post baseline, 12 months from baseline)
- Cost Analysis(At 12 months from baseline)
- Number of Subjects With Grade IIB and Higher Rejections at 6 Months and 12 Months Post Baseline(6 months post baseline, 12 months post baseline)
- Number of Clinic Visits(At 12 months from baseline)
- Number of Subjects With Grade IIA and Lower Rejections at 6 Months and 12 Months Post Baseline(6 months post baseline, 12 months post baseline)
- Number of Subjects With Human Leukocyte Antigen Donor Specific Antibodies (HLA DSA) at 6 Months and 12 Months Post Baseline(6 moths post baseline, 12 months post baseline)
- Number of Subjects Needing Hospitalizations(At 12 months from baseline)
- Number of Subjects Needing Transplant Biopsies at 12 Months Post Baseline(12 months post baseline)
研究者
Idelberto Badell
Assistant Professor
Emory University