A clinical trial to study Tocilizumab for treatment of chronic rejection due to antibodies in kidney transplant patients
- Conditions
- Treatment of chronic active antibody-mediated rejection in kidney transplant recipientsMedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2019-004302-10-SE
- Lead Sponsor
- Västra Götalandsregionen, Sahlgrenska University hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
1.The subject has given their written informed consent to participate in the study
2.Recipient of living donor or deceased donor kidney transplant
3.Age =18 years
4.At least 12 months post-transplantation at randomization
5.Biopsy-proven diagnosis of cAMR according to the Banff 2017 criteria in index biopsy. Repeat biopsy should be performed if the last biopsy is estimated to be older than 6 months (+ 2 weeks) at the projected time of randomization (Visit 2)
6.GFR =20 ml/min/1.73 m2
7.Epstein-Barr Virus (EBV) IgG-positive
8.For female participants of childbearing potential: use of adequate contraception and a negative pregnancy test
9.Subject known to have been previously had corona virus disease of 2019 (COVID-19) must meet all of the following conditions:
-Asymptomatic for at least 1 month before the start of screening
-Re-established on maintenance immunosuppressants for at least 2 weeks prior to the start of screening
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 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
1.Inability to tolerate any of the SOC treatment- tacrolimus, mycophenolate acid (MPA) or prednisolone
2.Recipient of multi-organ transplants
3.De novo or recurrent renal disease that, in the Investigator’s opinion, could adversely influence the current allograft
4.Active viral infections such as BK virus (BKV), cytomegalovirus (CMV), SARS COV-2 (COVID-19), EBV, hepatitis C virus (HCV) or hepatitis B virus (HBV) infections, based on polymerase chain reaction (PCR) testing
5.Ongoing serious infections as per Investigator’s opinion
6.History of recurrent serious infections requiring hospitalization
7.Signs of post-transplant lymphoproliferative disorder
8.History of tuberculosis (TB)
9.Active TB or latent TB (positive QuantiFERON-TB-Gold test, Chest X-ray)
10.Abnormal liver function tests alanine transaminase (ALT), aspartate transaminase (AST), bilirubin > 1.5 x upper limit of normal)
11.Other significant liver disease as per Investigator’s opinion
12.Neutropenia (<2 x109/L) or thrombocytopenia (<100 x109/L)
13.Signs of malignancy. Exceptions are basal cell carcinoma/squamous cell carcinoma or non-malignant melanoma
14.History of malignancy, unless subject has been considered to have fully recovered from malignancy since > 2 years, without any signs of relapse
15.History of diverticulitis, diverticulosis, gastrointestinal perforation or inflammatory bowel disease
16.Ongoing alcohol or illicit substance abuse
17.Serious medical or psychiatric illness likely to interfere with participation in the study as per Investigator’s opinion
18.Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
19.Woman of childbearing potential who is unwilling/unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug
20.Woman with a positive pregnancy test or who is pregnant or breastfeeding
21.Current or recent (within last 3 months) participation in another clinical drug trial
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