Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study

NCT01185197 | Completed Phase 4

• 1 other identifier: Novartis-ST-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Study objective: To investigate the potential therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for minimal change nephrotic syndrome (MCNS).

Conditions

Nephrosis, Lipoid

Keywords

Minimal Change Nephrotic Syndrome; Corticosteroid; Mycophenolate; Remission; Safety

Outcome Measures

Primary Outcomes (1)

• Complete remission (24 hour urine protein < 0.3 g)

  at 6 months

Secondary Outcomes (1)

• Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection

  at 6 months

Study Arms (2)

Myfortic plus low-dose steroid

EXPERIMENTAL

Not necessary

Drug: Myfortic plus low-dose steroid

Standard-dose steroid

ACTIVE COMPARATOR

Not necessary

Drug: Prednisolone

Interventions

Myfortic plus low-dose steroid DRUG

Prednisolone: 0.25 mg/kg/day for 8 weeks then 0.15 mg/kg/day for 8 weeks then 0.1 mg/kg/day for 8 weeks then off Myfortic: 720 mg b.i.d. (540 mg b.i.d. if body weight less than 60 kg) for 24 weeks then off

Also known as: Mycophenolate sodium

Myfortic plus low-dose steroid

Prednisolone DRUG

1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician

Standard-dose steroid

Eligibility Criteria

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

You may qualify if:

• Male or female 18 - 65 years of age
• First histologic diagnosis of MCNS
• Proteinuria \> 3.5 g/day
• Patients who are willing to give written, informed consent

You may not qualify if:

• Presence of secondary causes of MCNS
• History of glomerular disease including MCNS
• eGFR \< 50 ml/min/1.73m2
• Renal histology showing pathologies other than MCNS
• Female of child-bearing age who are unwilling to practice effective contraception
• Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

Location

Related Publications (2)

• Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.

  PMID: 35230699 DERIVED

• Ma MKM, Yap DYH, Li CL, Mok MMY, Chan GCW, Kwan LPY, Lai KN, Tang SCW. Low-dose corticosteroid and mycophenolate for primary treatment of minimal change disease. QJM. 2020 Jun 1;113(6):399-403. doi: 10.1093/qjmed/hcz297.

  PMID: 31769845 DERIVED

MeSH Terms

Conditions

Nephrosis, Lipoid

Interventions

Mycophenolic Acid; Steroids; Prednisolone

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes

Study Officials

• Sydney CW Tang, MD, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 19, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 1, 2018

Record last verified: 2018-05

Locations

CN (1)