- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048161
Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome (STAMP)
Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome: a Randomized, Multicenter, Open-label, Parallel-arm Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100032
- Peking University First Hospital
-
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Chongqing
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Chongqing, Chongqing, China, 401122
- Children's Hospital of Chongqing Medical University
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-
Guangdong
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Guangzhou, Guangdong, China, 510080
- First Affiliated Hospital of Zhongshan Medical University
-
-
Henan
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Zhengzhou, Henan, China, 451161
- Henan Children's Hospital
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Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital
-
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Hunan
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Changsha, Hunan, China, 410011
- Second Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, China, 210008
- Nanjing Children's Hospital
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Suzhou, Jiangsu, China, 215002
- Children's Hospital of Soochow University
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Shandong
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Jinan, Shandong, China, 250021
- Shandong Provincial Hospital
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Shanghai
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Shanghai, Shanghai, China, 201102
- Children's Hospital of Fudan University
-
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Shichuan
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Chengdu, Shichuan, China, 610043
- Chengdu Women and Children's Center Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310006
- The Children Hospital of Zhejiang University School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Sensitive but frequent relapses or steroids dependence nephrotic syndrome
- Age: 2 to 18 years old
- Normal renal function: estimated glomerular filtration rate ≥90ml/min/1.73m2
- Morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/mmol) for 3 consecutive days and above when in enroll
- No tacrolimus, mycophenolate mofetil, cyclosporine A, rituximab or cyclophosphamide was used within 2 years prior to the enrollment
Exclusion Criteria:
- steroids-resistant nephrotic syndrome
- Family history of nephrotic syndrome, chronic glomerulonephritis or uremia
- Leukopenia (White Blood Cells ≤ 3.0 * 10^9 / L)
- Moderate to severe anemia (hemoglobin <9.0 g/dL)
- Thrombocytopenia (platelet count <100*10^12/L)
- Positive Hepatitis B virus serological indicators (Hepatitis B surface antigen or / and Hepatitis B virus e antigen or / and Hepatitis B core antibody), Hepatitis C virus-positive or patients with abnormal liver function (2 or more times of alamine aminotransferase or total bilirubin was exceeded the normal value, and continued to rise for 2 weeks)
- There are chronic active infections such as Epstein-Barrvirus, cytomegalovirus or Mycobacterium tuberculosis, and the usage of steroids and immunosuppressive agents may aggravate the state of an illness
- Secondary nephrotic syndrome (such as purpuric nephritis, lupus nephritis, etc.)
- Those who with hematological or endocrine system diseases as well as serious organs illness such as heart, liver or kidney
- Those who with other autoimmune diseases or primary immunodeficiencies or tumors
- Those who was known to be sensitized to tacrolimus, mycophenolate mofetil, glucocorticoids, or any of the above drugs
- Those who have participated in other clinical trials within three months prior to the enrollment
- Those who was not suitable for participating this study judged by investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tacrolimus(Group A)
Tacrolimus: 0.5mg and 1mg; Capsule; 0.05-0.10mg/kg/day,BID;
Steroid: 5mg; Oral tablets; 1.0-1.5 mg/kg, qod or 0.5-0.75
mg/kg/day, qd;
|
The patients will be divided into two groups randomly. Tacrolimus dose: 0.05-0.10 mg/kg/day, BID. The concentration for tacrolimus is 5-10 ng/ml,then reduce the dosage of drugs to maintian the concentration for tacrolimus is < 5ng/ml. Total duration : 1 year. Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd, then gradually taper the steroid to 5mg/day.
Other Names:
|
Active Comparator: Mycophenolate Mofetil(Group B)
Mycophenolate Mofetil: 250mg; Dispersible tablets; 20~30mg/kg/day,BID; Steroid: 5mg; Oral tablets; 1.0-1.5 mg/kg, qod or 0.5-0.75
mg/kg/day, qd;
|
The patients will be divided into two groups randomly. Mycophenolate Mofetil dose: 20~30mg/kg/day,BID. The concentration for MPA-AUC is 30~50 μg.h/ml,then reduce the dosage of drugs to maintian the concentration for MPA-AUC is ≤40 μg.h/ml. Total duration : 1 year. Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd, then gradually taper the steroid to 5mg/day.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1-year relapse-free survival rate
Time Frame: 1-year period after randomization
|
The rate of no relapse within 1 year
|
1-year period after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse of nephrotic syndrome during 12 months after randomization
Time Frame: 1-year period after randomization
|
Proportion of patients with one or more relapse(s) of nephrotic syndrome
|
1-year period after randomization
|
Number of relapses during 12 months follow up
Time Frame: 1-year period after randomization
|
Number of nephrotic syndrome relapses per patient year during the 12 months period after randomization
|
1-year period after randomization
|
The first time to relapse
Time Frame: 1-year period after randomization
|
The first time to relapse after patients taking part in this study
|
1-year period after randomization
|
Cumulative prednisone dosage (milligrams per kilogram per year)
Time Frame: 1-year period after randomization
|
The total dosage of prednisones from the beginning to the end of the trial
|
1-year period after randomization
|
Change in serum cholesterol, hemoglobin and blood albumin of the patients
Time Frame: 1-year period after randomization
|
The changes of serum cholesterol, hemoglobin and blood albumin in each follow-up during the study
|
1-year period after randomization
|
Change in renal function of the patients
Time Frame: 1-year period after randomization
|
The change for renal function was judged by the changes of serum creatinine and estimated glomerular filtration rate in each follow-up during the study
|
1-year period after randomization
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Change in anthropometry and growth velocity during 12-month period after randomization
Time Frame: 1-year period after randomization
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Changes in standard deviation scores for weight, height and body mass index during 12-month period after randomization
|
1-year period after randomization
|
Adverse event
Time Frame: 1-year period after randomization
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The number of harmful reactions and the types of adverse events during the study
|
1-year period after randomization
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Jianhua Mao, MD, Children's Hospital, Zhejiang University School of Medicine
Publications and helpful links
General Publications
- Ren H, Shen P, Li X, Pan X, Zhang W, Chen N. Tacrolimus versus cyclophosphamide in steroid-dependent or steroid-resistant focal segmental glomerulosclerosis: a randomized controlled trial. Am J Nephrol. 2013;37(1):84-90. doi: 10.1159/000346256. Epub 2013 Jan 22.
- Filler G, Young E, Geier P, Carpenter B, Drukker A, Feber J. Is there really an increase in non-minimal change nephrotic syndrome in children? Am J Kidney Dis. 2003 Dec;42(6):1107-13. doi: 10.1053/j.ajkd.2003.08.010.
- Eddy AA, Symons JM. Nephrotic syndrome in childhood. Lancet. 2003 Aug 23;362(9384):629-39. doi: 10.1016/S0140-6736(03)14184-0.
- Wong W. Idiopathic nephrotic syndrome in New Zealand children, demographic, clinical features, initial management and outcome after twelve-month follow-up: results of a three-year national surveillance study. J Paediatr Child Health. 2007 May;43(5):337-41. doi: 10.1111/j.1440-1754.2007.01077.x.
- Tarshish P, Tobin JN, Bernstein J, Edelmann CM Jr. Prognostic significance of the early course of minimal change nephrotic syndrome: report of the International Study of Kidney Disease in Children. J Am Soc Nephrol. 1997 May;8(5):769-76. doi: 10.1681/ASN.V85769.
- Shaw KT, Ho AM, Raghavan A, Kim J, Jain J, Park J, Sharma S, Rao A, Hogan PG. Immunosuppressive drugs prevent a rapid dephosphorylation of transcription factor NFAT1 in stimulated immune cells. Proc Natl Acad Sci U S A. 1995 Nov 21;92(24):11205-9. doi: 10.1073/pnas.92.24.11205.
- Koefoed-Nielsen PB, Karamperis N, Hojskov C, Poulsen JH, Jorgensen KA. The calcineurin activity profiles of cyclosporin and tacrolimus are different in stable renal transplant patients. Transpl Int. 2006 Oct;19(10):821-7. doi: 10.1111/j.1432-2277.2006.00359.x.
- Neidle S, Goodwin GH. A homology-based molecular model of the proline-rich homeodomain protein Prh, from haematopoietic cells. FEBS Lett. 1994 May 30;345(2-3):93-8. doi: 10.1016/0014-5793(94)00446-3.
- Sepe V, Libetta C, Giuliano MG, Adamo G, Dal Canton A. Mycophenolate mofetil in primary glomerulopathies. Kidney Int. 2008 Jan;73(2):154-62. doi: 10.1038/sj.ki.5002653. Epub 2007 Nov 7.
- Briggs WA, Choi MJ, Scheel PJ Jr. Successful mycophenolate mofetil treatment of glomerular disease. Am J Kidney Dis. 1998 Feb;31(2):213-7. doi: 10.1053/ajkd.1998.v31.pm9469489.
- Gellermann J, Weber L, Pape L, Tonshoff B, Hoyer P, Querfeld U; Gesellschaft fur Padiatrische Nephrologie (GPN). Mycophenolate mofetil versus cyclosporin A in children with frequently relapsing nephrotic syndrome. J Am Soc Nephrol. 2013 Oct;24(10):1689-97. doi: 10.1681/ASN.2012121200. Epub 2013 Jun 27.
- Schwartz GJ, Brion LP, Spitzer A. The use of plasma creatinine concentration for estimating glomerular filtration rate in infants, children, and adolescents. Pediatr Clin North Am. 1987 Jun;34(3):571-90. doi: 10.1016/s0031-3955(16)36251-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Syndrome
- Nephrotic Syndrome
- Nephrosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Tacrolimus
- Mycophenolic Acid
Other Study ID Numbers
- STAMP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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