A multicenter, two arm, randomized, open label clinical study investigating renal function in an advagraf®-based immunosupressive regimen with or without sirolimus in kidney transplant subjects. - ADHERE

Astellas Pharma B.V.0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 30

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•Subject is eligible for the study if all of the following apply:
•1. Age >= 18 years.
•2. End stage kidney disease and a suitable candidate for primary renal transplantation or retransplantation (unless the graft was lost from rejection within 6 months).
•3. Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] identical) donor with compatible ABO blood type.
•4. Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment.
•5. Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/286/ 95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner.
•6. Capable of understanding the purpose and risks of the study, fully informed and having given written informed consent (signed Informed Consent has been obtained).

排除标准

•Subject will be excluded from participating if any of the following apply:
•1. Receiving or having previously received an organ transplant other than a kidney.
•2. Cold ischemia time of the donor kidney > 30 hours.
•3. Panel Reactive Antibody (PRA) >20%.
•4. Receiving a graft from a non-heart-beating donor other than of Maastricht category 3
•(withdrawal of support awaiting cardiac arrest).
•5. Significant liver disease, defined as having continuously elevated SGPT/ ALT and/ or
•SGOT/ AST and/ or total bilirubin levels >= 2 times the upper value of the normal range of
•the investigational site or is receiving a graft from a hepatitis C or B positive donor.
•6. Requiring initial sequential or parallel therapy with immunosuppressive antibody
•preparation(s).
•7. Requiring ongoing dosing with a systemic immunosuppressive drug prior to
•transplantation (other than minimal levels of immunosuppression following failure of
•previous transplantation without nephrectomy).
•8. Significant, uncontrolled concomitant infections and/ or severe diarrhea, vomiting, active
•upper gastro-intestinal tract malabsorption or active peptic ulcer.
•9. Pregnant woman or breast-feeding mother.
•10. Subject or donor known to be HIV positive.
•11. Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids,
•sirolimus, MMF or any of the product excipients or iodine.
•12. Evidence of malignant disease within the last 5 years, not including non-malignant skin
•13. Currently participating in another clinical trial, and/ or has taken an investigational drug
•within 28 days prior to enrollment.
•14. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of
•the Investigator, may complicate communication with the Investigator.
•15. Unlikely to comply with the visits scheduled in the protocol

研究者

发起方

Astellas Pharma B.V.

相似试验

尚未招募

3 期

A randomized, multicentril, open label, comparative efficacy study in healthy child.

CTRI/2022/01/039575Zydus Wellness Products Limited

进行中（未招募）

不适用

A multicenter, two arms, randomized, open label clinical Phase IV study investigating the proportion of CMV seropositive kidney transplant recipients who will develop a CMV infection within the first 6 months post-transplantation when treated with an immunosuppressive regimen including everolimus (Certican®) and reduced dose of cyclosporine A (Néoral®) versus an immunosuppressive regimen with mycophenolic acid (Myfortic®) and standard dose of cyclosporine A (Néoral®). - EVERCMVCMV infection in CMV-seropositive de novo kidney transplant recipients receiving an immunosuppressive regimen.

EUCTR2013-003195-12-FRCHU de Bordeaux

招募中

2 期

Role and effect of Capsule HRPT-091514 as an add treatment to normal standard treatment in patient with chronic kidney disease.

CTRI/2020/12/029519The Himalaya Drug Company

尚未招募

3 期

controlled trial of SHIRO KLOMAN treatment in mild to moderate symptomatic patients with SARS-CoV-2 Infection (Covid-19).

CTRI/2021/09/036100Bindi Prashant Shah

已完成

3 期

A clinical trial to know the efficacy and safety of herbal product Virowin in combination with Energy-Z capsule in treating mild to moderate COVID-19 patients.

CTRI/2020/08/027120Amulya Herbs60