Iguratimod in Kidney Transplant Recipients

NCT ID: NCT02839941

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-07-31

Brief Summary

The objective of the study is to evaluate the effect of iguratimod concomitant with conventional immunosuppressive drugs on preventing antibody-induced rejection in HLA Highly mismatched Kidney Transplant recipients.

Conditions

Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experiment

Group Type: EXPERIMENTAL

Iguratimod

Intervention Type: DRUG

Subjects will receive iguratimod orally, twice a day, for consecutive 52 weeks

Mycophenolate mofetil

Intervention Type: DRUG

All subjects will receive mycophenolate mofetil for consecutive 52 weeks

Tacrolimus

Intervention Type: DRUG

All subjects will receive tacrolimus for consecutive 52 weeks

Glucocorticoids

Intervention Type: DRUG

All subjects will receive glucocorticoids for consecutive 52 weeks

Control

Group Type: SHAM_COMPARATOR

Mycophenolate mofetil

Intervention Type: DRUG

All subjects will receive mycophenolate mofetil for consecutive 52 weeks

Tacrolimus

Intervention Type: DRUG

All subjects will receive tacrolimus for consecutive 52 weeks

Glucocorticoids

Intervention Type: DRUG

All subjects will receive glucocorticoids for consecutive 52 weeks

Interventions

Iguratimod

Subjects will receive iguratimod orally, twice a day, for consecutive 52 weeks

Intervention Type: DRUG

Mycophenolate mofetil

All subjects will receive mycophenolate mofetil for consecutive 52 weeks

Intervention Type: DRUG

Tacrolimus

All subjects will receive tacrolimus for consecutive 52 weeks

Intervention Type: DRUG

Glucocorticoids

All subjects will receive glucocorticoids for consecutive 52 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female, aged ≥18, <65 years
• At least 2 weeks post kidney transplantation from deceased or living donor
• Stable renal graft function, i.e., serum creatinine undulation for 3 consecutive test <±10%
• Serum creatinine<1.5×upper limits of normal(ULN)
• Number of HLA mismatches ≥ 4
• Panel Reactive Antibody(PRA) value pre-transplantation <10%
• Concentration of conventional immunosuppressive drugs reach target ranges
• Subjects are willing to participate in the study, fully informed, and sign informed consent form(ICF)
• Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study medication, and agree to use an acceptable method to avoid pregnancy for the entire study period and for up to 3 months after the last dose of study medication.

Exclusion Criteria

• Pregnant or nursing women
• Currently clinical acute rejection;
• Graft function hasn't recovered for delayed graft function (DGF), or primary non-function (PNF)
• Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas)
• Subjects with Liver failure
• Abnormal hepatic, renal and hematopoietic function,

1. Alanine transaminase(ALT), Aspartate transaminase(AST)>1.5×ULN

2. White blood cell(WBC)<3.5×10^9/L

3. Hemoglobin(HGB)<80 g/L

4. Platelet count(PLT)<80×10^9/L.

• Severe clinically relevant disease,

1. Abnormality in chest X ray image, such as Tuberculosis, Pulmonary interstitial fibrosis, or symptom or physical sign of clinical significance

2. Serious cardiovascular, hepatic, hematological, endocrinal disease, or malignancy 3）History of serious cardiovascular, hepatic, hematological, endocrinal disease, or malignancy

4) Immunodeficiency, uncontrolled active infection, and active gastrointestinal disease.

• Women or men of childbearing potential plan to be pregnant recently;
• Allergic with study drug, or excipient
• Subject with psychiatric illness, which may put him/her into unacceptable risk in the opinion of investigators
• Has received or is receiving Rituximab treatment
• Iguratimod treatment within 1 week pre-transplantation, or during screening period
• Received live vaccines in the previous 3 months, or plan to receive live vaccines during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Gu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hao Chen

Role: CONTACT

chenhao_nju@sina.com

Other Identifiers

KT-2016-1

Identifier Type: -

Identifier Source: org_study_id