Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 1163 for:    MYCOPHENOLIC ACID

The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients (MAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01854814
Recruitment Status : Recruiting
First Posted : May 16, 2013
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Fan Fan Hou, Nanfang Hospital of Southern Medical University

Brief Summary:
The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on time to doubling of serum creatinine or the onset of end stage renal disease in patients with advanced IgA nephropathy who are treated with the maximal tolerated daily dose of losartan.The study will also assess the effects of MMF compared with losartan alone on the changes of urine albumin excretion and the changes in estimated glomerular filtration rate.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: Mycophenolate mofetil Drug: Losartan Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Mycophenolate Mofetil on Renal Outcomes in Patients With Advanced IgA Nephropathy: a Randomized Open-label Study
Study Start Date : July 2013
Estimated Primary Completion Date : June 2018


Arm Intervention/treatment
Experimental: mycophenolate mofetil
mycophenolate mofetil 1.5g/day and maximum tolerated labeled dose of losartan
Drug: Mycophenolate mofetil
Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan

Active Comparator: losartan
maximus tolerated labeled dose of losartan
Drug: Losartan
Maximum tolerated labeled dose of Losartan




Primary Outcome Measures :
  1. To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy [ Time Frame: 3 years ]

    Time to the first occurrence of a component of the composite renal endpoint:

    Doubling of serum creatinine or the onset of end stage renal disease (ESRD) [needing chronic dialysis or renal transplantation or renal death]


  2. To evaluate the effects of mycophenolate mofetil on progression of CKD in subjects with advanced IgA nephropathy [ Time Frame: 3 years ]

    A decrease in eGFR of 30% or more and to a level of less than 60 ml/min at the exit visit if the baseline eGFR was 60 ml/min or more.

    Or a decrease in eGFR of 50% or more at the exit visit if the baseline eGFR was less than 60 ml/min.



Secondary Outcome Measures :
  1. To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy [ Time Frame: 3 years ]
    Changes of urinary protein excretion rate

  2. To evaluate the effects of mycophenolate mofetil rapid progression of CKD in subjects with advanced IgA nephropathy [ Time Frame: 3 years ]
    Time to 30% reduction in estimated glomerular filtration rate (eGFR); eGFR reduction greater than 5 ml/min/1.73m^2/year



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy-proven primary IgA nephropathy with urinary proteinuria excretion over 1g/24 hour,subjects must meet 2 of the following criteria:

    1. global glomerular sclerosis plus focal segmental glomerular sclerosis ratio ≥50%
    2. eGFR 30 to 60 ml/min
    3. Hypertension (blood pressure over 140/90 mmHg or taking antihypertensive drugs)

Exclusion Criteria:

  1. Secondary IgA nephropathy
  2. Familial IgA nephropathy
  3. Concomitant disease: cancer, infection, diabetes mellitus, connective tissue disease, abnormal liver function
  4. Pregnancy or breasting
  5. Inability to comply with study and follow-up procedures

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): NCT01854814


Contacts
Layout table for location contacts
Contact: Fan Fan Hou, M.D.,PhD 0086-20-61641591 ffhouguangzhou@163.com

Locations
Layout table for location information
China, Guangdong
Nanfang Hospital Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Jun Wang, doctor    0086-020-61641591    wangjun1975@smu.edu.cn   
Sub-Investigator: Min Liang, doctor         
Sub-Investigator: Jun Wang, doctor         
Sub-Investigator: Xun Zhang, doctor         
Sub-Investigator: Jun Ai, doctor         
The Fourth People's Hospital Shenzhen Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Tiecheng Yang, MD    008613823123966    Yangtcpro@163.com   
Principal Investigator: Tiecheng Yang, MD         
The Institute of Nephrology, Guangdong Medical College Recruiting
Zhanjiang, Guangdong, China, 524001
Contact: Hua-feng Liu, PhD, MD    0759-2387583    hf-liu@263.net   
Principal Investigator: Hua-feng Liu, PhD, MD         
Sponsors and Collaborators
Fan Fan Hou
Investigators
Layout table for investigator information
Principal Investigator: Fan Fan Hou, M.D., PhD Division of nephrology, Nanfang Hospital Southern Medical University

Publications:
Layout table for additonal information
Responsible Party: Fan Fan Hou, Chief of Division of Nephrology, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01854814     History of Changes
Other Study ID Numbers: MAIN
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Mycophenolic Acid
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Losartan
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists