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Corticosteroid

Reduced-Dose Steroids for Nephrotic Syndrome (RESPONSE Trial)

Phase 3
Waitlist Available
Led By Rulan Parekh, MD MS
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of idiopathic nephrotic syndrome (defined as nephrotic-range proteinuria [first morning or 24-hour urine protein/creatinine ratio ≥200mg/mmol or ≥3+ protein on dipstick] and either hypoalbuminemia [serum albumin <30g/L] or edema)
Ability to take oral medication and willingness to adhere to either study prednisone regimen
Must not have
Active or prior known or suspected venous thromboembolism during a relapse episode
Relapse episode within the past 6-weeks (i.e., date of relapse onset within 6-weeks prior to date of enrolment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is a small study done before a larger study to see if using a lower dose of oral steroids is safe and effective in treating a type of kidney disease in children called steroid-sensitive nephrotic

Who is the study for?
This trial is for children with steroid-sensitive nephrotic syndrome, which includes conditions like lipoid nephrosis and minimal change disease. Participants must be able to take oral medication.
What is being tested?
The study tests a reduced-dose of the oral medication prednisone against the standard dose typically used to treat relapses of childhood nephrotic syndrome. It's an initial test run at one medical center before a larger study.
What are the potential side effects?
Prednisone can cause weight gain, increased appetite, high blood pressure, mood swings, and weakened bones. Long-term use might lead to more serious effects such as eye problems or slower growth in children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a specific kidney condition involving high protein in urine, low blood protein, or swelling.
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I can take pills and will follow the study's prednisone plan.
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I am currently experiencing a relapse of nephrotic syndrome.
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I am between 1 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had blood clots during a relapse of my condition.
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My condition worsened again less than 6 weeks ago.
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I am currently on a high-dose prednisone therapy.
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My kidney condition was diagnosed before I turned 1 or is caused by a single gene.
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I have experienced a recent worsening in my kidney function.
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I have severe swelling in my limbs that leaves a deep indent.
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I have been hospitalized for my current relapse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Study recruitment rate
Secondary study objectives
Adverse events
Cumulative steroid dose
Hospitalizations
+7 more

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Dysphagia-esophageal radiation
8%
Hypoglycemia
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Reduced-dose steroidsExperimental Treatment1 Intervention
Reduced-dose steroid protocol (intervention): oral prednisone or prednisolone 30mg/m2 (1mg/kg; max 40mg) daily until remission, then 20mg/m2 (0.66mg/kg; max 25mg) on alternate days for four weeks.
Group II: Standard-dose steroidsActive Control1 Intervention
Standard-dose steroid protocol (control): oral prednisone or prednisolone 60mg/m2 (2mg/kg; max 60mg) daily until remission, then 40mg/m2 (1.5mg/kg; max 50mg) on alternate days for four weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2500

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
707 Previous Clinical Trials
6,957,424 Total Patients Enrolled
1 Trials studying Nephrotic Syndrome
1,000 Patients Enrolled for Nephrotic Syndrome
Rulan Parekh, MD MSPrincipal InvestigatorThe Hospital for Sick Children
~33 spots leftby Oct 2025
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