NCT02839941

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

2.9 years

First QC Date

July 19, 2016

Last Update Submit

August 27, 2018

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

  • Biopsy-proven acute rejection rates

    0-52 week

  • Survival of transplanted kidney

    52 week

Secondary Outcomes (3)

  • Donor Specific Antibody(DSA) level compared to baseline

    52 week

  • Graft renal function

    52 week

  • Adverse event

    0-52 week

Study Arms (2)

experiment

EXPERIMENTAL
Drug: IguratimodDrug: Mycophenolate mofetilDrug: TacrolimusDrug: Glucocorticoids

Control

SHAM COMPARATOR
Drug: Mycophenolate mofetilDrug: TacrolimusDrug: Glucocorticoids

Interventions

IguratimodDRUG

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

experiment
Mycophenolate mofetilDRUG

All subjects will receive mycophenolate mofetil for consecutive 52 weeks

Controlexperiment
TacrolimusDRUG

All subjects will receive tacrolimus for consecutive 52 weeks

Controlexperiment
GlucocorticoidsDRUG

All subjects will receive glucocorticoids for consecutive 52 weeks

Controlexperiment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • Alanine transaminase(ALT), Aspartate transaminase(AST)\>1.5×ULN
  • White blood cell(WBC)\<3.5×10\^9/L
  • Hemoglobin(HGB)\<80 g/L
  • Platelet count(PLT)\<80×10\^9/L.
  • Severe clinically relevant disease,
  • Abnormality in chest X ray image, such as Tuberculosis, Pulmonary interstitial fibrosis, or symptom or physical sign of clinical significance
  • Serious cardiovascular, hepatic, hematological, endocrinal disease, or malignancy 3）History of serious cardiovascular, hepatic, hematological, endocrinal disease, or malignancy
  • \) Immunodeficiency, uncontrolled active infection, and active gastrointestinal disease.
  • Women or men of childbearing potential plan to be pregnant recently;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

iguratimodMycophenolic AcidTacrolimusGlucocorticoids

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsMacrolidesLactonesAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Min Gu

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Chen

CONTACT

chenhao_nju@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 21, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)