Kidney TransplantationNCT02839941
Iguratimod in Kidney Transplant Recipients
A study testing Iguratimod, Mycophenolate mofetil and Tacrolimus in people with Kidney Transplantation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Iguratimod, Mycophenolate mofetil and Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- 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.
Who cannot join
- 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,
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- 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
- 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.
Trial locations and contacts
1 site in 1 country.
Hao Chen contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
About this study
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
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
- Being tested
- Iguratimod, Mycophenolate mofetil, Tacrolimus, Glucocorticoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IguratimodDrug
Subjects will receive iguratimod orally, twice a day, for consecutive 52 weeks
All subjects will receive mycophenolate mofetil for consecutive 52 weeks
TacrolimusDrug
All subjects will receive tacrolimus for consecutive 52 weeks
GlucocorticoidsDrug
All subjects will receive glucocorticoids for consecutive 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| experiment | Experimental | Not described Receives: Drug: Iguratimod; Drug: Mycophenolate mofetil; Drug: Tacrolimus; Drug: Glucocorticoids |
| Control | Sham comparator | Not described Receives: Drug: Mycophenolate mofetil; Drug: Tacrolimus; Drug: Glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy-proven acute rejection rates
Measured: 0-52 week
Survival of transplanted kidney
Measured: 52 week
Secondary outcomes (3)
Donor Specific Antibody(DSA) level compared to baseline
Measured: 52 week
Graft renal function
Measured: 52 week
Adverse event
Measured: 0-52 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Gu, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839941
- Sponsor's protocol ID
- KT-2016-1
- Status last verified
- Aug 2018
- First submitted
- 19 Jul 2016
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02839941
- Acronym / sponsor ID
- KT-2016-1
- Conditions
- Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment | Experimental | Drug: Iguratimod, Drug: Mycophenolate mofetil, Drug: Tacrolimus, Drug: Glucocorticoids |
| Control | Sham comparator | Drug: Mycophenolate mofetil, Drug: Tacrolimus, Drug: Glucocorticoids |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IguratimodSubjects will receive iguratimod orally, twice a day, for consecutive 52 weeks | Drug | experiment |
| Mycophenolate mofetilAll subjects will receive mycophenolate mofetil for consecutive 52 weeks | Drug | Control, experiment |
| TacrolimusAll subjects will receive tacrolimus for consecutive 52 weeks | Drug | Control, experiment |
| GlucocorticoidsAll subjects will receive glucocorticoids for consecutive 52 weeks | Drug | Control, experiment |
Primary outcome
Biopsy-proven acute rejection rates
Time frame: 0-52 week
Survival of transplanted kidney
Time frame: 52 week
3 secondary outcomes
Donor Specific Antibody(DSA) level compared to baseline
Time frame: 52 week
Graft renal function
Time frame: 52 week
Adverse event
Time frame: 0-52 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No
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Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Chen contact
Min Gu principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iguratimod, Mycophenolate mofetil and Tacrolimus in people with Kidney Transplantation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Chen (chenhao_nju@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biopsy-proven acute rejection rates (time frame: 0-52 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.