Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01162005
First received: July 12, 2010
Last updated: July 13, 2010
Last verified: July 2010
  Purpose

The use of tacrolimus in NS(nephrotic syndrome) has been reported in single and small series case reports. To determine the efficacy of tacrolimus in the management of NS, the investigators designed this prospective study. The investigators will enroll 100 children with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs, multivitamins and lipid-lowering agents.

Follow-up is every second week for the first 4 weeks, then monthly. After initiation of tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels. Subsequently , monthly measurements were made until stable levels of tacrolimus were achieved. Urine was analyzed for proteinuria at each visit. Serum creatinine, glucose, albumin and alanine aminotransferase were measured and complete blood counts were obtained at each visit during the study.


Condition Intervention Phase
Nephrotic Syndrome
Drug: Tacrolimus
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Partial or complete Remission rate of Steroid resistant nephrotic syndrome [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total remission duration [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus Drug: Tacrolimus
dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Frequent relapse nephrotic syndrome
  • steroid resistance nephrotic syndrome

Exclusion Criteria:

  • secondary nephrotic syndrome
  • estimated GFR < 60 mL/min/1.73m2
  • with active hepatitis
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162005

Contacts
Contact: ILSOO Ha, MD, PhD 82-2-2072-3584 ilsooha@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: IlSoo Ha, MD, PhD    82-2-2072-3584    ilsooha@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Chong Kun Dang Pharmaceutical
  More Information

No publications provided

Responsible Party: Il Soo Ha, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01162005     History of Changes
Other Study ID Numbers: INS-Tacrobell, INS-Tacrobell-Pediatrics
Study First Received: July 12, 2010
Last Updated: July 13, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Primary Nephrotic syndrome

Additional relevant MeSH terms:
Nephrotic Syndrome
Syndrome
Disease
Kidney Diseases
Nephrosis
Pathologic Processes
Urologic Diseases
Tacrolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014