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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02532777
Date of registration:	20/08/2015
Prospective Registration:	No
Primary sponsor:	Nanjing Children's Hospital
Public title:	The Research of Standard Diagnosis and Treatment for HSPN in Children
Scientific title:	The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children
Date of first enrolment:	August 2015
Target sample size:	100
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02532777
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
Phase:	Phase 2

Countries of recruitment
China

Contacts

Name:	Aihua Aihua, M.D.
Address:
Telephone:	+8618951769017
Email:	bszah@163.com
Affiliation:

Name:	Aihua Zhang, M.D.
Address:
Telephone:
Email:
Affiliation:	Department of Nephrology, Nanjing children's hospital

Name:	Aihua Zhang, M.D.
Address:
Telephone:	+8618951769017
Email:	bszah@163.com
Affiliation:

Key inclusion & exclusion criteria

Inclusion Criteria:

- Renal biopsy proved HSPN Proteinuria = 50 mg/kg/d

Exclusion Criteria:

- The children with congenital diseases Proteinuria < 50 mg/kg/d

Age minimum: 2 Years
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Henoch-Schoenlein Purpura Nephritis

Intervention(s)

Drug: Cyclophosphamide(CTX)

Drug: Methylprednisolone

Drug: Mycophenolate mofetil(MMF)

Drug: Leflunomide(LEF)

Drug: Prednisone

Drug: Angiotensin-converting enzyme inhibitor(ACEI)

Primary Outcome(s)

Disappearance of proteinuria [Time Frame: 30 mo]

Secondary Outcome(s)

Renal function [Time Frame: 30 mo]

Disappearance of hematuria [Time Frame: 30 mo]

Secondary ID(s)

AZhang

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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