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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experiment | Experimental |
| |
| Control | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iguratimod | Drug | Subjects will receive iguratimod orally, twice a day, for consecutive 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy-proven acute rejection rates | 0-52 week | |
| Survival of transplanted kidney | 52 week |
| Measure | Description | Time Frame |
|---|---|---|
| Donor Specific Antibody(DSA) level compared to baseline | 52 week | |
| Graft renal function | 52 week | |
| Adverse event |
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Inclusion Criteria:
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,
Severe clinically relevant disease,
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Chen | Contact | chenhao_nju@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Gu | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| C519076 | iguratimod |
| D009173 | Mycophenolic Acid |
| D016559 | Tacrolimus |
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Mycophenolate mofetil | Drug | All subjects will receive mycophenolate mofetil for consecutive 52 weeks |
|
| Tacrolimus | Drug | All subjects will receive tacrolimus for consecutive 52 weeks |
|
| Glucocorticoids | Drug | All subjects will receive glucocorticoids for consecutive 52 weeks |
|
| 0-52 week |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D007783 | Lactones |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |