Rituximab and Targeted Nursing for Pediatric Nephrotic Syndrome

About this trial

Last updated 8 months ago

Study ID

WX19Q09

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

6 to 15 Years

All Sexes

Trial Timing

Ended 2 years ago

What is this trial about?

This study investigated the combined impact of rituximab and targeted nursing care versus tacrolimus and targeted nursing care on efficacy, quality of life, adverse reactions, and recurrence rate in children with challenging (steroid-dependent or frequently relapsing) nephrotic syndrome. Ninety-one pediatric patients were randomized to either receive rituximab plus targeted nursing or tacrolimus plus targeted nursing, and outcomes were assessed over a 6-month period.

What are the participation requirements?

Inclusion Criteria

* Diagnosis of primary pediatric nephrotic syndrome, specifically steroid-dependent nephrotic syndrome (SDNS) or frequently relapsing nephrotic syndrome (FRNS), as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. (SDNS is defined as relapse occurring during tapering of glucocorticoids or within 14 days of discontinuation; FRNS is defined as ≥2 relapses within 6 months of initial response or ≥4 relapses in any 12-month period).

* Age between 6 and 15 years.

* Normal intellectual development and the ability to understand and communicate.

* Informed consent obtained from the guardians and assent from children capable of understanding.

Exclusion Criteria

* Steroid-resistant nephrotic syndrome (SRNS).

* Severe renal insufficiency (according to KDIGO criteria or other relevant standards).

* Cognitive or mental disorders.

* Worsening condition upon admission necessitating intensive care.

* Parents unable to provide long-term care or unwilling to participate.

* Interruption of hospitalization for any reason.

* Prior treatment with rituximab or tacrolimus.

* Co-existing significant kidney, urinary system diseases (other than NS), or severe active urinary tract infection.

* Significant liver function impairment.

* Known hypersensitivity to rituximab or tacrolimus.