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Completed

NCT Number: NCT01185197

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

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).

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Key information

Conditions

Nephrosis, Lipoid Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Queen Mary Hospital

Hong Kong, China

About this study

This is a prospective, open-label, randomized study in which patients who present for the first time with a clinical diagnosis of idiopathic MCNS proven on renal biopsy will be assigned to either conventional standard-dose prednisolone monotherapy or myfortic combined with low-dose prednisolone treatment for 6 months. Clinical response and relapse rates within 6 months of treatment cessation will be the main outcome parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: Mycophenolate sodium

Prednisolone

Drug

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

Primary outcomes

  1. Complete remission (24 hour urine protein < 0.3 g)

    Time frame: at 6 months

Secondary outcomes

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

    Time frame: at 6 months

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Aug 19, 2010
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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