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Trial record 78 of 1164 for:    MYCOPHENOLIC ACID

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

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ClinicalTrials.gov Identifier: NCT01185197
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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).

Condition or disease Intervention/treatment Phase
Nephrosis, Lipoid Drug: Myfortic plus low-dose steroid Drug: Prednisolone Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome
Study Start Date : September 2010
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: Myfortic plus low-dose steroid
Not necessary
Drug: Myfortic plus low-dose steroid
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 Name: Mycophenolate sodium

Active Comparator: Standard-dose steroid
Not necessary
Drug: Prednisolone
1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician




Primary Outcome Measures :
  1. Complete remission (24 hour urine protein < 0.3 g) [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection [ Time Frame: at 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01185197


Locations
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China
Queen Mary Hospital
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Sydney CW Tang, MD, PhD The University of Hong Kong

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01185197     History of Changes
Other Study ID Numbers: Novartis-ST-03
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

Keywords provided by The University of Hong Kong:
Minimal Change Nephrotic Syndrome
Corticosteroid
Mycophenolate
Remission
Safety

Additional relevant MeSH terms:
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Mycophenolic Acid
Nephrotic Syndrome
Nephrosis
Nephrosis, Lipoid
Kidney Diseases
Urologic Diseases
Prednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone Acetate
Methylprednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents