Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid in Advanced IgA Nephropathy

IgA Nephropathy Clinical Trial

— AIGA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02981212
• Other study ID #: 062IGA15-1D
• Status: Recruiting
• Phase: Phase 4
• First received: November 24, 2016
• Last updated: November 30, 2016
• Start date: June 2016
• Est. completion date: October 2018

Study information

• Verified date: November 2016
• Source: Yonsei University
• Contact: EUNJU JUNG
• Phone: 82-10-5414-7760
• Email: oakly74[@]nate.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria

1. Patient aged 19 to 65 years old

2. Diagnosed with IgA nephropathy

3. Confirmed with Proteinuria more than 1.0 g / day at least twice within 6 months from the time of screening

4. If eGFR (by MDRD) is <50 mL / min / 1.73 m^2, = 15 mL / min / 1.73 m^2

5. ACE inhibitor or ARB for at least 3 months

6. Willing and able to provide written informed consent.

Exclusion Criteria:

1. If eGFR (by MDRD) is <15 mL / min / 1.73 m^2

2. Blood pressure is SBP> 160 mmHg or DBP> 100 mmHg

3. Systemic infection or have been diagnosed with cancer within the last 5 years (excluding treatment squamous cell or basal cell carcinoma skin cancer)

4. serious digestive disorder

5. WBC <3000 / mm^3

6. Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs

7. Administration of other Investigational drugs within 28days before screening period

8. Administration of Investigator drug or other immunosuppressants within 84days before screening period

9. Women in pregnant or breast-feeding or don't using adequate contraception.

10. Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.

11. In investigator's judgment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

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
• ACE inhibitor
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
• Corticosteroid
combination with Mycophenolate Mofetil
• ARB
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (8)

Lead Sponsor	Collaborator
Yonsei University	Chonbuk National University Hospital, Chong Kun Dang Pharmaceutical Corp., Inje University, Kyung Hee University Hospital at Gangdong, Kyungpook National University, Pusan National University Yangsan Hospital, Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate (complete / partial)		up to 48 weeks	No
Secondary	Remission rate (complete / partial)		at 12 weeks, at 24 weeks, at 36 weeks	No
Secondary	eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease)		at 24 weeks, at 36 weeks, at 48 weeks	No
Secondary	The incidence of renal replacement therapy	renal replacement therapy; dialysis, new transplant	up to 48 weeks	No
Secondary	The average time to occurrence of renal replacement therapy	renal replacement therapy; dialysis, new transplant	up to 48 weeks	No