Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
Recruitment status was Recruiting
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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 |
- Partial or complete Remission rate of Steroid resistant nephrotic syndrome [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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 |
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| Contact: ILSOO Ha, MD, PhD | 82-2-2072-3584 | ilsooha@snu.ac.kr |
| 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 | |
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 Nephrosis Kidney Diseases Urologic Diseases Tacrolimus |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012
