Iguratimod in Kidney Transplant Recipients

An Open-label Study to Evaluate the Effect of Iguratimod Concomitant With Conventional Immunosuppressive Drugs on Preventing Antibody-induced Rejection in Human Leukocyte Antigen(HLA) Highly Mismatched Kidney Transplant Recipients

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: Iguratimod; Drug: Mycophenolate mofetil; Drug: Tacrolimus; Drug: Glucocorticoids

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hao Chen; Email: chenhao_nju@sina.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • The First Affiliated Hospital with Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control	Drug: Mycophenolate mofetil; All subjects will receive mycophenolate mofetil for consecutive 52 weeks; Drug: Tacrolimus; All subjects will receive tacrolimus for consecutive 52 weeks; Drug: Glucocorticoids; All subjects will receive glucocorticoids for consecutive 52 weeks
Experimental: experiment	Drug: Iguratimod; Subjects will receive iguratimod orally, twice a day, for consecutive 52 weeks; Drug: Mycophenolate mofetil; All subjects will receive mycophenolate mofetil for consecutive 52 weeks; Drug: Tacrolimus; All subjects will receive tacrolimus for consecutive 52 weeks; Drug: Glucocorticoids; All subjects will receive glucocorticoids for consecutive 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biopsy-proven acute rejection rates	0-52 week
Survival of transplanted kidney	52 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Donor Specific Antibody(DSA) level compared to baseline	52 week
Graft renal function	52 week
Adverse event	0-52 week

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Principal Investigator: Min Gu, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Calcineurin Inhibitors; Tacrolimus; Mycophenolic Acid; Glucocorticoids
• Other Study ID Numbers: KT-2016-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO