Extended Follow-Up After Islet Transplantation in Type 1 Diabetes (CIT-08)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 8
- 主要终点
- Duration of sustained islet allograft function
研究概览
简要总结
The purpose of this study is to provide patients who have received at least one islet transplant as a previous participant in a Clinical Islet Transplantation Consortium (CIT) clinical trial with maintenance immunosuppressive medications and to collect information about the safety of the medications and islet function.
详细描述
After islet-cell transplantation in the CIT studies*, each subject receives maintenance immunosuppressive medications.
The purpose of this protocol is to collect additional follow-up for safety and efficacy from CIT subjects with graft function after their completion in their CIT parent study. It is expected that most subjects will retain measurable islet function and, in the islet-alone studies, continue to receive immunosuppressive medications at the time of completing their CIT parent study.
*CIT parent studies: CIT02 (NCT00464555), CIT03 (NCT00434850), CIT04 (NCT00468403), CIT05 (NCT00468442), CIT06 (NCT00468117), and CIT07 (NCT00434811)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have received an islet transplant during participation in the following Clinical Islet Transplantation (CIT) parent studies: CIT02 (NCT00464555), CIT03 (NCT00434850), CIT04 (NCT00468403), CIT05 (NCT00468442), CIT06 (NCT00468117), and CIT07 (NCT00434811)
- •A functioning pancreatic islet graft (e.g., absence of graft failure as defined in parent study) requiring immunosuppression
- •Willingness of participants to continue to use an approved method of contraception during and 4 months after study participation
- •Ability to provide written informed consent
- •Resident of the United States of America
- •Documentation of the existence or lack of health insurance coverage and whether immunosuppressants are covered.
排除标准
- •For female subjects-Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation
- •For male subjects-Intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
- •Received an islet transplant in a non-CIT research study
- •Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
研究组 & 干预措施
CIT Islet Transplantation Recipients
Subjects who received an islet-cell transplant for Type 1 Diabetes (T1D) while enrolled in one of the Clinical Islet Transplantation (CIT) parent studies and continue to have islet graft function. All subjects will continue immunosuppressive medications under CIT08. Detailed follow-up evaluations including but not limited to islet function will occur on an annual basis.
The immunosuppressive medications (e.g., tacrolimus, sirolimus, cyclosporine, mycophenolate mofetil [MMF], mycophenolic sodium) in this study are obtained by prescription unless provided by the study through the drug distributor. Generic brands are allowed, when available. Antibacterial, antifungal, and antiviral prophylaxis, insulin therapy, and other standard therapies will be provided per site-specific practices.
干预措施: Maintenance Immunosuppressive Treatment (Drug)
结局指标
主要结局
Duration of sustained islet allograft function
时间窗: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant
A C-peptide \>/= 0.3 ng/mL at 0, 60, or 90 minutes after a Mixed-Meal Tolerance Test (MMTT) will be considered evidence of insulin production by transplanted islets
次要结局
- Serum creatinine and calculated eGFR at each annual study visit(Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant)
- Incidence of serious adverse events (SAEs) during the 12-month period preceding each annual study visit(Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant)
- Insulin requirements during a one-week period preceding each annual study visit(Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant)
- Incidence of all-cause mortality(By month 144 status post last islet transplant)
- Incidence of severe hypoglycemic events during the 12-month period preceding each annual study visit(36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months, 132 months and 144 months)
- HbA1c levels at each annual study visit(Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant)
- Donor-specific alloantibodies(By month 144 status post last islet transplant)