Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid in Advanced IgA Nephropathy (AIGA)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02981212 |
|
Recruitment Status :
Recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
|
Sponsor:
Yonsei University
Collaborators:
Chong Kun Dang Pharmaceutical Corp.
Kyung Hee University Hospital at Gangdong
Kyungpook National University
Pusan National University Yangsan Hospital
Inje University
Seoul St. Mary's Hospital
Chonbuk National University Hospital
Information provided by (Responsible Party):
Beom Seok Kim, Yonsei University
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Mycophenolate Mofetil in combination with corticosteroid in patients with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without administration of Mycophenolate Mofetil.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| IgA Nephropathy | Drug: Mycophenolate Mofetil Drug: ACE inhibitor Drug: Corticosteroid Drug: ARB | Phase 4 |
The subject who signed the written agreement to participate in the clinical trial evaluates the conformity and then 1: 1 randomly allocated.
The study group were taken 48 weeks with MYREPT ® capsules in combination with corticosteroids and the control group were asked to preserve the conservative treatment regimen prior to the clinical trial registration Maintenance.
The subject who started taking the study medicine will carry out the examination and procedure if it has to be carried out for the visit via outpatient clinic at 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Multi-center, Randomized, Open Label, Comparative, Phase IV Study to Evaluate the Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid for 48 Weeks in Advanced IgA Nephropathy |
| Study Start Date : | June 2016 |
| Estimated Primary Completion Date : | August 2018 |
| Estimated Study Completion Date : | October 2018 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Mycophenolate Mofetil
MYREPT® capsule(CKDpharm, KOREA) and corticosteroid
|
Drug: Mycophenolate Mofetil
less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally
Other Name: MYREPT® Drug: Corticosteroid combination with Mycophenolate Mofetil
Other Names:
|
|
Active Comparator: Conservative treatment
maintain conservative treatment (ACE inhibitor or ARB)
|
Drug: ACE inhibitor
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
Other Name: conservative treatment Drug: ARB maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
Other Name: conservative treatment |
Primary Outcome Measures :
- Remission rate (complete / partial) [ Time Frame: up to 48 weeks ]
Secondary Outcome Measures :
- Remission rate (complete / partial) [ Time Frame: at 12 weeks, at 24 weeks, at 36 weeks ]
- eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease) [ Time Frame: at 24 weeks, at 36 weeks, at 48 weeks ]
- The incidence of renal replacement therapy [ Time Frame: up to 48 weeks ]renal replacement therapy; dialysis, new transplant
- The average time to occurrence of renal replacement therapy [ Time Frame: up to 48 weeks ]renal replacement therapy; dialysis, new transplant
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 19 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Patient aged 19 to 65 years old
- Diagnosed with IgA nephropathy
- Confirmed with Proteinuria more than 1.0 g / day at least twice within 6 months from the time of screening
- If eGFR (by MDRD) is <50 mL / min / 1.73 m^2, ≥ 15 mL / min / 1.73 m^2
- ACE inhibitor or ARB for at least 3 months
- Willing and able to provide written informed consent.
Exclusion Criteria:
- If eGFR (by MDRD) is <15 mL / min / 1.73 m^2
- Blood pressure is SBP> 160 mmHg or DBP> 100 mmHg
- Systemic infection or have been diagnosed with cancer within the last 5 years (excluding treatment squamous cell or basal cell carcinoma skin cancer)
- serious digestive disorder
- WBC <3000 / mm^3
- Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs
- Administration of other Investigational drugs within 28days before screening period
- Administration of Investigator drug or other immunosuppressants within 84days before screening period
- Women in pregnant or breast-feeding or don't using adequate contraception.
- Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.
- In investigator's judgment
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981212
Contacts
| Contact: EUNJU JUNG | 82-10-5414-7760 | oakly74@nate.com | |
| Contact: JONGHYUK LEE | 82-10-5599-1199 | leejongh@ckdpharm.com |
Locations
| Korea, Republic of | |
| Severance Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: EUNU JUNG 82-10-5414-7760 oakly74@nate.com | |
| Principal Investigator: CHANDUK KIM, PhD | |
| Principal Investigator: DONGWON LEE, PhD | |
| Principal Investigator: SANGHO LEE, PhD | |
| Principal Investigator: BUMSOON CHOI, PhD | |
| Principal Investigator: SANGYEOB HAN, PhD | |
| Principal Investigator: SIK LEE, PhD | |
Sponsors and Collaborators
Yonsei University
Chong Kun Dang Pharmaceutical Corp.
Kyung Hee University Hospital at Gangdong
Kyungpook National University
Pusan National University Yangsan Hospital
Inje University
Seoul St. Mary's Hospital
Chonbuk National University Hospital
Investigators
| Principal Investigator: | BEOMSUK KIM | Severance Hospital |
| Responsible Party: | Beom Seok Kim, Professor, Yonsei University |
| ClinicalTrials.gov Identifier: | NCT02981212 History of Changes |
| Other Study ID Numbers: |
062IGA15-1D |
| First Posted: | December 5, 2016 Key Record Dates |
| Last Update Posted: | December 5, 2016 |
| Last Verified: | November 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Kidney Diseases Glomerulonephritis, IGA Urologic Diseases Glomerulonephritis Nephritis Autoimmune Diseases Immune System Diseases Mycophenolic Acid Angiotensin-Converting Enzyme Inhibitors |
Antibiotics, Antineoplastic Antineoplastic Agents Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protease Inhibitors |