Nephrotic Syndrome in ChildrenNCT07049172
Rituximab and Targeted Nursing for Pediatric Nephrotic Syndrome
A study testing Rituximab, Targeted Nursing Care and Baseline Glucocorticoid Therapy in people with Nephrotic Syndrome in Children, run by Wuhan Children's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Nephrotic Syndrome in Children
- What is being tested?
- Rituximab, Targeted Nursing Care and Baseline Glucocorticoid Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Rituximab in Reducing Relapses in Children With Steroid-Sensitive Nephrotic Syndrome: An Open-label, Multi-center Clinical Study.
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.
Read the detailed description
Nephrotic syndrome in children, particularly steroid-dependent (SDNS) or frequently relapsing (FRNS) types, poses significant treatment challenges. While glucocorticoids are initial mainstays, second-line immunosuppressants like tacrolimus or rituximab are often required. Rituximab, a monoclonal antibody targeting CD20 on B-lymphocytes, has shown promise. Targeted nursing care, a patient-centered approach involving joint goal-setting and personalized interventions, aims to improve adherence and overall well-being. This study aimed to evaluate the synergistic effect of rituximab therapy combined with a structured targeted nursing care program compared to tacrolimus with the same targeted nursing care.
A total of 91 pediatric patients (aged 6-15 years) with SDNS or FRNS were enrolled from January 2021 to June 2023. They were randomized into a study group (n=46, rituximab + targeted nursing) and a control group (n=45, oral tacrolimus + targeted nursing). Both groups received baseline glucocorticoid therapy. The study group received intravenous rituximab (375 mg/m² weekly for 12 weeks). The control group received oral tacrolimus (0.05-0.1 mg/kg/day, adjusted to trough levels). Both groups received identical targeted nursing care protocols.
Outcomes compared included clinical efficacy (remission status), quality of life (IS-LQ questionnaire), incidence of adverse reactions, and recurrence rate over a 6-month follow-up. Peripheral blood CD19+ B-cell counts were monitored in the rituximab group. The study was approved by the institutional ethics committee, and informed consent was obtained.
- Conditions
- Nephrotic Syndrome in Children
- Being tested
- Rituximab, Targeted Nursing Care, Baseline Glucocorticoid Therapy, Tacrolimus
- Keywords
- rituximab, targeted nursing care, pediatric nephrotic syndrome, tacrolimus, steroid-dependent nephrotic syndrome, frequently relapsing nephrotic syndrome
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan®
- Dosage: 375 mg/m²
- Route: Intravenous infusion
- Frequency: Once a week
- Duration: 12 consecutive weeks
- Details: Diluted in 5% glucose solution. Infusion started at 25 ml/h, increased by 25 ml/h every 30 minutes if no adverse reactions, up to 100-150 ml/h.
Targeted Nursing CareBehavioural
A structured, individualized nursing approach involving joint goal-setting. Included health education, psychological support, relaxation techniques, dietary care, lifestyle guidance, complication management, and medication guidance. Delivered throughout hospital stay and reinforced during monthly follow-ups.
Baseline Glucocorticoid TherapyDrug
Patients already on maintenance glucocorticoids continued their regimen. For relapse at admission, IV methylprednisolone (2 mg/kg/day), then oral prednisone (2 mg/kg/day, max 60mg/day) tapered according to standard protocols.
TacrolimusDrug
Also called Prograf®
- Dosage: Initial dose 0.05-0.1 mg/kg/day, adjusted to maintain target trough levels of 5-10 ng/mL.
- Route: Oral
- Frequency: Divided into two doses (morning and evening)
- Duration: Throughout the 6-month study period.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab with Targeted Nursing Care | Experimental | Patients received intravenous rituximab in conjunction with baseline glucocorticoid therapy and a standardized targeted nursing care program Receives: Drug: Rituximab; Behavioral: Targeted Nursing Care; Drug: Baseline Glucocorticoid Therapy |
| Tacrolimus with Targeted Nursing Care | Active comparator | Patients received oral tacrolimus capsules in conjunction with baseline glucocorticoid therapy and a standardized targeted nursing care program identical to the study group. Receives: Behavioral: Targeted Nursing Care; Drug: Baseline Glucocorticoid Therapy; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Effective Rate
The percentage of participants who achieved a "Significantly effective" or "Effective" response. Efficacy is defined based on remission status, renal function, and proteinuria levels. Total effective rate is calculated as the number of (Significantly effective + Effective) cases divided by the total number of cases in the group.
Measured: At 6 months post-treatment initiation.
Recurrence Rate
Relapse defined as urinary protein ≥2+ or urinary protein quantity >50 mg/kg (or urine protein/creatinine ratio >2.0 mg/mg), occurring on three consecutive days within a 7-day period, after having achieved remission.
Measured: Within the 6-month follow-up period after treatment initiation.
Secondary outcomes (2)
Change in Quality of Life as Assessed by the Children's Subjective Quality of Life Questionnaire (IS-LQ)
The IS-LQ consists of 60 items, scored from 1 to 4, with higher scores indicating better quality of life. Assesses six areas including cognitive, emotional, and overall functioning.
Measured: Baseline and at 6 months post-treatment initiation.
Adverse Reactions
Any adverse reactions recorded, including infections, infusion reactions (for rituximab), hypertension, hyperglycemia, electrolyte disturbances, and gastrointestinal symptoms.
Measured: During the 6-month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nephrotic Syndrome in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Xu, Wuhan Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049172
- Sponsor's protocol ID
- WX19Q09
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He L, Mei H, Gu Y, Liu Z, Yang L, Li X, Wang X, Xu T. Combined impact of rituximab and target care on efficacy, quality of life, adverse reactions and recurrence rate in children with nephrotic syndrome: a randomized controlled trial. BMC Pediatr. 2025 Sep 24;25(1):691. doi: 10.1186/s12887-025-06070-0.
PubMed 40993587
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rituximab in Reducing Relapses in Children With Steroid-Sensitive Nephrotic Syndrome: An Open-label, Multi-center Clinical Study.
- ClinicalTrials.gov ID
- NCT07049172
- Acronym / sponsor ID
- WX19Q09
- Conditions
- Nephrotic Syndrome in Children
- Keywords
- rituximab, targeted nursing care, pediatric nephrotic syndrome, tacrolimus, steroid-dependent nephrotic syndrome, frequently relapsing nephrotic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Wuhan Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nephrotic syndrome in children, particularly steroid-dependent (SDNS) or frequently relapsing (FRNS) types, poses significant treatment challenges. While glucocorticoids are initial mainstays, second-line immunosuppressants like tacrolimus or rituximab are often required. Rituximab, a monoclonal antibody targeting CD20 on B-lymphocytes, has shown promise. Targeted nursing care, a patient-centered approach involving joint goal-setting and personalized interventions, aims to improve adherence and overall well-being. This study aimed to evaluate the synergistic effect of rituximab therapy combined with a structured targeted nursing care program compared to tacrolimus with the same targeted nursing care.
A total of 91 pediatric patients (aged 6-15 years) with SDNS or FRNS were enrolled from January 2021 to June 2023. They were randomized into a study group (n=46, rituximab + targeted nursing) and a control group (n=45, oral tacrolimus + targeted nursing). Both groups received baseline glucocorticoid therapy. The study group received intravenous rituximab (375 mg/m² weekly for 12 weeks). The control group received oral tacrolimus (0.05-0.1 mg/kg/day, adjusted to trough levels). Both groups received identical targeted nursing care protocols.
Outcomes compared included clinical efficacy (remission status), quality of life (IS-LQ questionnaire), incidence of adverse reactions, and recurrence rate over a 6-month follow-up. Peripheral blood CD19+ B-cell counts were monitored in the rituximab group. The study was approved by the institutional ethics committee, and informed consent was obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab with Targeted Nursing Care | Experimental | Drug: Rituximab, Behavioral: Targeted Nursing Care, Drug: Baseline Glucocorticoid TherapyPatients received intravenous rituximab in conjunction with baseline glucocorticoid therapy and a standardized targeted nursing care program |
| Tacrolimus with Targeted Nursing Care | Active comparator | Behavioral: Targeted Nursing Care, Drug: Baseline Glucocorticoid Therapy, Drug: TacrolimusPatients received oral tacrolimus capsules in conjunction with baseline glucocorticoid therapy and a standardized targeted nursing care program identical to the study group. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: Rituxan®* Dosage: 375 mg/m² * Route: Intravenous infusion * Frequency: Once a week * Duration: 12 consecutive weeks * Details: Diluted in 5% glucose solution. Infusion started at 25 ml/h, increased by 25 ml/h every 30 minutes if no adverse reactions, up to 100-150 ml/h. | Drug | Rituximab with Targeted Nursing Care |
| Targeted Nursing CareA structured, individualized nursing approach involving joint goal-setting. Included health education, psychological support, relaxation techniques, dietary care, lifestyle guidance, complication management, and medication guidance. Delivered throughout hospital stay and reinforced during monthly follow-ups. | Behavioural | Rituximab with Targeted Nursing Care, Tacrolimus with Targeted Nursing Care |
| Baseline Glucocorticoid TherapyPatients already on maintenance glucocorticoids continued their regimen. For relapse at admission, IV methylprednisolone (2 mg/kg/day), then oral prednisone (2 mg/kg/day, max 60mg/day) tapered according to standard protocols. | Drug | Rituximab with Targeted Nursing Care, Tacrolimus with Targeted Nursing Care |
| TacrolimusAlso: Prograf®* Dosage: Initial dose 0.05-0.1 mg/kg/day, adjusted to maintain target trough levels of 5-10 ng/mL. * Route: Oral * Frequency: Divided into two doses (morning and evening) * Duration: Throughout the 6-month study period. | Drug | Tacrolimus with Targeted Nursing Care |
Primary outcome
Total Effective Rate
Time frame: At 6 months post-treatment initiation.
The percentage of participants who achieved a "Significantly effective" or "Effective" response. Efficacy is defined based on remission status, renal function, and proteinuria levels. Total effective rate is calculated as the number of (Significantly effective + Effective) cases divided by the total number of cases in the group.
Recurrence Rate
Time frame: Within the 6-month follow-up period after treatment initiation.
Relapse defined as urinary protein ≥2+ or urinary protein quantity >50 mg/kg (or urine protein/creatinine ratio >2.0 mg/mg), occurring on three consecutive days within a 7-day period, after having achieved remission.
2 secondary outcomes
Change in Quality of Life as Assessed by the Children's Subjective Quality of Life Questionnaire (IS-LQ)
Time frame: Baseline and at 6 months post-treatment initiation.
Adverse Reactions
Time frame: During the 6-month study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 40993587He L, Mei H, Gu Y, Liu Z, Yang L, Li X, Wang X, Xu T. Combined impact of rituximab and target care on efficacy, quality of life, adverse reactions and recurrence rate in children with nephrotic syndrome: a randomized controlled trial. BMC Pediatr. 2025 Sep 24;25(1):691. doi: 10.1186/s12887-025-06070-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab, Targeted Nursing Care and Baseline Glucocorticoid Therapy in people with Nephrotic Syndrome in Children, run by Wuhan Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Effective Rate (time frame: At 6 months post-treatment initiation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07049172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.