A trial to understand whether GSK1070806 improves renal transplant function immediately and in the long term after transplantatio
- Conditions
- Delayed Graft Function in Adult Subjects After Renal Transplantation.MedDRA version: 19.0Level: HLTClassification code 10074474Term: Transplantation complicationsSystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2015-002812-33-ES
- Lead Sponsor
- GlaxoSmithKline, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 7
1. Recipient age range: 18 years of age and older, at the time of signing the informed consent.
2. Dialysis-dependent recipient of first time or second time, single kidney-only, Donation after Circulatory Death (DCD) transplant.
-Donor kidney must be ‘controlled’ meeting either Maastricht Category 3 or 4 criteria:
Category 3: Donor awaiting cardiac arrest
Category 4: Cardiac arrest in a brain stem dead donor
3. Eligible for kidney transplantation: Considered eligible for transplantation after undergoing multidisciplinary evaluation at the institution at which the transplantation will be performed.
4. Immunosuppressants (at the time of transplantation): planned to receive a combination of immunosuppressants including basiliximab, mycophenolate mofetil or azathioprine, tacrolimus, and corticosteroids.
5. Male and Female:
Males: Male subjects with female partners of child bearing potential must utilize a condom and female partners must comply with use of one of the highly effective contraceptive methods described in Appendix 4 of the protocol for 180 days post-dose of study medication.
Females:
a. Non-reproductive potential defined as:
• Females with one of the following procedures documented and no plans to utilize assisted reproductive techniques (e.g., in vitro fertilization or donor embryo transfer):
- Bilateral tubal ligation or salpingectomy
- Hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
- Hysterectomy
- Bilateral Oophorectomy (surgical menopause)
• Postmenopausal defined as 12 months of spontaneous amenorrhea.
- In questionable cases (including cases in which amenorrhea is suspected to result from a subject’s poor renal function/dialysis) a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause are required. If FSH/estradiol results are not available in time subjects are to be initiated on contraceptive methods (see below and Appendix 4 of the protocol).
- Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study.
b. Reproductive potential. Must not be pregnant or lactating, and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (see Appendix 4 of the protocol) for 180 days post dose. If a hormonal method of birth control is selected from the list in Appendix 4 of the protocol, then subjects must have been using these methods at least 28 days prior to GSK1070806 administration, or be abstinent, or utilize a condom as a method of contraception until the selected hormonal method has been in place for the 28 day period.
The investigator is responsible for ensuring that subjects understand how to properly use the indicated methods of contraception by providing counsel directly or by referring subjects to health care professionals with expertise in this area.
6. Capable of providing signed informed consent as described in Section 10.2 which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this
1. Liver function: ALT >2xULN and bilirubin >1.5xULN (view protocol for further information)
2. QT interval: single or average QTc > 480 msec or in subjects with bundle branch block QTc > 500 msec (view protocol for further information)
3. Concurrent medication: Subjects who receive treatment that is prohibited for safety reasons, should not receive investigational product without the explicit approval of the Medical Monitor (Sponsor)
4. Investigational product: Any within 5 half-lives or twice the duration of the biological effect whichever is longer.
5. Immunosuppression: Are being considered for steroid-free, anti-thymocyte globulin (ATG) or alemtuzumab induction, which have a much more profound and prolonged immunosuppressive effect than basiliximab.
6. Prior biologic immunosuppressives: please view protocol for further information.
7. Vaccines: A live vaccine within 30 days prior to GSK1070806 administration.
8. Receiving a DCD kidney allograft from a donor with any of the following characteristics
a. cold ischemic time > 36 hours
b. age < 5 years old
c. ABO blood type incompatible against the recipient.
d. T- and/or B-cell positive crossmatch by complement dependent cytotoxicity or flow cytometry against the recipient.
e. serology positive for hepatitis B (except hepatitis B surface antibody and prior vaccination), hepatitis C or human immunodeficiency virus (HIV)
f. EBV positive donor allograft with an EBV negative recipient
g. donor had acute or chronic bacterial, viral or fungal infection that according to the investigator causes a risk to recipient, particularly if the infection was resistant or systemic
h. normothermic regional machine perfusion organ retrieval techniques were utilized
i. surgical damage to donor allograft during organ procurement (view protocol for further information)
j. ‘Uncontrolled’ Maastricht Category 1, Category 2, and Category 5 (view protocol for further information)
9. Previous organ transplantation (view protocol for further information)
10. Malignancy: has a history of malignancy in the past 5 years except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
11. Acute or chronic infection: has required management of acute or chronic infections (excludes prophylaxis of infections), as follows:
a. currently being treated for a chronic infection, which in the opinion of the investigator, could put the subject at undue risk
b. hospitalized for treatment of infection, or treated for an infection with parenteral antibiotics within 30 days before Day 0, which in the opinion of the investigator, could put the subject at undue risk.
c. current evidence, or history within the last 14 days, of an influenza-like illness as defined by fever (>38°C) and two or more of the following symptoms: cough, sore throat, runny nose, sneezing, limb / joint pain, headache, vomiting / diarrhoea
d. patients with any history of active tuberculosis, view protocol for further information.
12. Other disease/conditions. Has any of the following:
a. clinical evidence of significant unstable or uncontrolled acute or chronic diseases, which in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
b. a surgical procedure planned in the 12 months after Day 0, other than kidney transplantation or related procedure
c. a known history of any other medical disease (view protocol for further information)
13. Hepatitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method