Preceding Study Toward Establishing Optimal Blood Concentrations of Mycophenolate Mofetil

JRCT ID: jRCT1031230722

Registered date:20/03/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Pediatric steroid-resistant nephrotic syndrome
Pediatric renal transplant recipients

• Date of first enrollment: 13/03/2024
• Target sample size: 50
• Study type: Observational

Outcome(s)

• Primary Outcome: The predicted area under the curve (AUC 0-12) of MPA during pediatric SRNS (induction of remission, maintenance of remission, refractory cases, relapse, onset of side effects) and pediatric renal transplant treatment (transplant induction, transplant induction rejection, transplant maintenance, transplant maintenance rejection, onset of side effects) based on MPA blood concentrations (before MMF ingestion, 1 hour after ingestion, 2 hours after ingestion, 3 hours after ingestion or 4 hours after ingestion, 6 hours after ingestion).
• Secondary Outcome: The correlation between MPA blood concentration and the following factors: side effects, serum albumin levels, serum creatinine levels, cyclosporine blood concentration, and tacrolimus blood concentration.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 20age old
• Gender: Both
• Include criteria: Children with steroid-resistant nephrotic syndrome or pediatric renal transplant recipients who are currently receiving outpatient care or hospitalized at the Pediatric Department of Jichi Medical University , and who have passed at least 7 days after the introduction of mycophenolate mofetil (MMF).
• Exclude criteria: Children who do not meet the selection criteria

Related Information

• Primary Sponsor: Ono Marika