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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Rigors/chills

Dizziness/lightheadedness

Injection site reaction

Dysphagia-esophageal radiation

Hypoglycemia

Blood bilirubin increased

Chest pain

Pain-other

Phlebitis

Creatinine increased

Edema

Pruritus

Hot flashes

Infection w/ grade 3 or 4 neutropenia

Weight loss

Muscle weakness

Depression

Mouth dryness

Transfusion: pRBCs

Pneumonitis/pulmonary infiltrates

Thrombosis/embolism

Febrile neutropenia

Irregular menses

Nail changes

Allergic rhinitis

Allergic reaction

Infection w/ unknown ANC

Syncope

Sinus tachycardia

Dehydration

Neuropathic pain

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Stanford V)

Arm A (ABVD)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 11Eligibility criteria met