EUCTR2014-004101-33-Outside-EU/EEA进行中（未招募）不适用
A Clinical Study to Evaluate the Efficacy and Safety of Cyclosporine (CsA) and Sirolimus (SRL) Induction Followed by Cyclosporine Withdrawal in Korean Renal Allograft Recipients
Wyeth Korea, Inc.0 个研究点目标入组 79 人开始时间: 2015年4月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 79
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age great than (>) 13 years
- •2. End-stage renal disease, with subjects receiving a primary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. A mismatch is defined as a donor human leukocyte antigen (HLA) antigen not shared by the patient.
- •3. All female subjects at risk for pregnancy must have a negative pregnancy test result before sirolimus administration, and must agree and commit to the use of a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study medication. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Any female subject who becomes pregnant during the treatment period must be discontinued from the on-therapy portion of the study.
- •4. Total white blood cell count greater than or equal to (>=) 4,000/ cubic millimeter (mm^3) (4.0 *10^9 /liter [L]), platelet count >= 100,000/mm^3 (100 x 10 9/L, fasting triglycerides >=400 milligram per deciliter (mg/dL), and fasting cholesterol >= 300 mg/dl. If it is not possible to obtain fasting triglycerides and cholesterol before surgery, historical values less than (<) 1 year may be used.
- •5. Signed and dated informed consent (parent or legal guardian must provide consent for patients <18 years of age). If possible, an assent form will be signed by patients <18 years of age enrolled in the study.
- •6. Patients with a panel of reactive antibody (%PRA) less than equal to (<=) 50 percent (%).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 22
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 57
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Evidence of active systemic or localized major infection at the time of initial sirolimus administration.
- •2. Evidence of infiltration, cavitation, or consolidation on chest x-ray obtained during pre-study screening
- •3. Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery
- •4. History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
- •5. Use of any investigational drug during the 4 weeks before enrolling in the study.
- •6. Presence of 4 or more HLA mismatches.
- •7. Active gastrointestinal disorder that may interfere with drug absorption.
- •8. Known hypersensitivity to sirolimus or its derivatives.
- •9. Multiple organ transplants
研究者
相似试验
尚未招募
2 期
Treatment of ithy, red, dry and cracked skin condition (Eczema) by of Unani drugCTRI/2017/12/010957Central Research Institute of Unani Medicine
已完成
2 期
A Clinical Study to Evaluate the Efficacy and Safety of JR-031 in Patients with Epidermolysis BullosaEpidermolysis BullosaJPRN-UMIN000026645Osaka University6
招募中
不适用
Evaluation of the usefulness and safety of the combined use of an ear prosthesis and a cartilage conduction hearing aidJPRN-UMIN000044711Keio University30
已完成
2 期
Clinical comparative efficacy and safety of Polyherbal Unani formulations.CTRI/2023/02/049696State Unani Medical College, himmatganj Prayagraj40
尚未招募
2 期
Effectiveness of Unani Drugs in High Blood PressureCTRI/2017/12/011006Central Research Institute of Unani Medicine