Iguratimod in Kidney Transplant Recipients

• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02839941
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: Iguratimod; Drug: Mycophenolate mofetil; Drug: Tacrolimus; Drug: Glucocorticoids	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Aug 1, 2016
• Anticipated Primary Completion Date: Jul 1, 2019
• Anticipated Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures

1. Biopsy-proven acute rejection rates [0-52 week]

2. Survival of transplanted kidney [52 week]

Secondary Outcome Measures

1. Donor Specific Antibody(DSA) level compared to baseline [52 week]

2. Graft renal function [52 week]

3. Adverse event [0-52 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

• The First Affiliated Hospital with Nanjing Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Affiliated Hospital with Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT02839941
• Other Study ID Numbers: KT-2016-1
• First Posted: Jul 21, 2016
• Last Update Posted: Aug 29, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Mycophenolic Acid; Tacrolimus; Glucocorticoids

Study Results

No Results Posted as of Aug 29, 2018