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

NCT02981212 | Unknown Phase 4 DMC

• 1 other identifier: 062IGA15-1D
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• Remission rate (complete / partial)

  up to 48 weeks

Secondary Outcomes (4)

• Remission rate (complete / partial)

  at 12 weeks, at 24 weeks, at 36 weeks

• eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease)

  at 24 weeks, at 36 weeks, at 48 weeks

• The incidence of renal replacement therapy

  up to 48 weeks

• The average time to occurrence of renal replacement therapy

  up to 48 weeks

Study Arms (2)

Mycophenolate Mofetil

EXPERIMENTAL

MYREPT® capsule(CKDpharm, KOREA) and corticosteroid

Drug: Mycophenolate Mofetil; Drug: Corticosteroid

Conservative treatment

ACTIVE COMPARATOR

maintain conservative treatment (ACE inhibitor or ARB)

Drug: ACE inhibitor; Drug: ARB

Interventions

Mycophenolate Mofetil DRUG

less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally

Also known as: MYREPT®

Mycophenolate Mofetil

ACE inhibitor DRUG

maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization

Also known as: conservative treatment

Conservative treatment

Corticosteroid DRUG

combination with Mycophenolate Mofetil

Also known as: prednisolone, methyprednisolone

Mycophenolate Mofetil

ARB DRUG

maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization

Also known as: conservative treatment

Conservative treatment

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead
• Chong Kun Dang Pharmaceutical Corp.: collaborator
• Kyung Hee University Hospital at Gangdong: collaborator
• Kyungpook National University Hospital: collaborator
• Pusan National University Yangsan Hospital: collaborator
• Inje University: collaborator
• Seoul St. Mary's Hospital: collaborator
• Chonbuk National University Hospital: collaborator

Study Sites (1)

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Mycophenolic Acid; Angiotensin-Converting Enzyme Inhibitors; Conservative Treatment; Adrenal Cortex Hormones; Prednisolone

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Therapeutics; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• BEOMSUK KIM

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

EUNJU JUNG

CONTACT

82-10-5414-7760; oakly74@nate.com

JONGHYUK LEE

CONTACT

82-10-5599-1199; leejongh@ckdpharm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 5, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 5, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)