A Phase 2 interventional study of Prednisone and Cyclophosphamide(CTX) in Henoch-Schoenlein Purpura Nephritis, sponsored by Nanjing Children's Hospital. Status unknown at 1 site in China. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Nanjing Children's Hospital · Phase 2, Interventional, and Treatment
This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children.
Henoch-Schonlein purpura nephritis (HSPN) is one of the most common complications of Henoch-Schonlein purpura, and has become one of the main causes of chronic kidney disease in children. However, the diagnosis and treatment of HSPN is still based on the clinical experience, lacking of evidence-based support. This study is performed to explore the biological marker for early prediction of the prognosis and evaluate the efficacy and safety of various measures in the treatment of HSPN in children.
The patients who are proved to get HSPN by renal biopsy will be given prednisone 2mg/kg/d, and randomized to receive cyclophosphamide pulse i.v.,mycophenolate mofetil p.o. or leflunomide p.o., we will follow up them for about 2.5 years and compare the efficacy and safety of these measures by monitoring several indexes.
36 studies on the registry are indexed under IgA Vasculitis; 12 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 19 interventional studies indexed under IgA Vasculitis.
Browse IgA Vasculitis studies →Nanjing Children's Hospital is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: prednisone \& cyclophosphamide \& Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod. cyclophosphamide: 0.1mg/kg. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
Drug: Prednisone · Drug: Cyclophosphamide(CTX) · Drug: Angiotensin-converting enzyme inhibitor(ACEI) · Drug: Methylprednisolone
Drug: prednisone \& mycophenolate mofetil \& Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod. mycophenolate mofetil: 25mg/kg/d bid (the maximum dose is 1.5g/d). Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
Drug: Prednisone · Drug: Mycophenolate mofetil(MMF) · Drug: Angiotensin-converting enzyme inhibitor(ACEI) · Drug: Methylprednisolone
Drug: prednisone \& leflunomide \& Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod. Leflunomide: give patients the induction dose 1mg/kg/d for three days (the total dose is under 40mg/kg)，then give the maintaining dose 0.5mg/kg/d. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
Drug: Prednisone · Drug: Leflunomide(LEF) · Drug: Angiotensin-converting enzyme inhibitor(ACEI) · Drug: Methylprednisolone
Also known as: Lotensin
Disappearance of proteinuria
The proteinuria is \< 150mg/d
Time frame: 30 mo
Disappearance of hematuria
The number of red blood cells is \< 3 in each high power field of vision
Time frame: 30 mo
Renal function
The glomerular filtration rate is normal
Time frame: 30 mo
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cyclophosphamide · Mycophenolic Acid · Leflunomide
Nanjing Children's Hospital