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Idiopathic Nephrotic SyndromePhase 3NCT03298698

Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome

A Phase 3 study testing Rituximab and Prednisone in people with Idiopathic Nephrotic Syndrome and Minimal Change Disease, run by Radboud University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This will be an open-label, randomized controlled trial which compares continued treatment with high dose prednisone (standard therapy) to treatment with rituximab in patients with minimal change disease or focal segmental glomerulosclerosis unresponsive to 8 weeks of high dose prednisone . Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rituximab and Prednisone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteNetherlands
Study dates
22 Aug 2018to 22 Jan 2022
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Persistent proteinuria ≥ 2 g/ 24 hours or a protein-to-creatinine ratio ≥ 2 g/10mmol (2 g/g) after 8 weeks of treatment with high dose prednisone 1 mg/kg/day (max 80 mg/day)
  • Idiopathic nephrotic syndrome caused by biopsy proven minimal change disease or focal segmental glomerulosclerosis

Who cannot join

  • Severe nephrotic syndrome with hypotension
  • Previous treatment with immunosuppressive medication other than prednisone
  • Treatment with prednisone > 10 weeks in last six months
  • Secondary form of FSGS or minimal change disease
  • Patients who test positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc).
  • Patients infected with HIV or suffering from other active infections
Show all 18Show fewer
  • Patients inoculated with a vaccine within 4 weeks prior to inclusion
  • Pregnancy, breast feeding, women with inadequate contraception
  • Malignancy
  • Kidney transplantation
  • Previous treatment with monoclonal antibodies within 2 years prior to inclusion
  • Neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L
  • Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
  • Active peptic ulcer
  • Known hypersensitivity to glucocorticoids
  • Insulin resistant diabetes mellitus
  • Treatment with carbamazepine, phenobarbital, phenytoin en rifampicin
  • Severe osteoporosis with vertebral fracture

Trial locations and contacts

1 site in 1 country.

Jeroen Deegens, MD,PhD contact

+31243614761

Jeroen.Deegens@radboudumc.nl

Netherlands1 site, 1 recruiting

  • Radboud University Medical Center

    Nijmegen, 6500HB

    Jeroen K Deegens, MD, PhD, +31243614761, Jeroen.Deegens@radboudumc.nl

    Jack F Wetzels, MD, PhD, +31243614761, Jack.Wetzels@radboudumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome Unresponsive to 8 Weeks of High Dose Prednisone

This will be an open-label, randomized controlled trial which compares continued treatment with high dose prednisone (standard therapy) to treatment with rituximab in patients with minimal change disease or focal segmental glomerulosclerosis unresponsive to 8 weeks of high dose prednisone .

patients either receive 2 doses of Rituximab 375 mg/m2 iv at time 0 and 14 days with termination of prednisone or standard therapy which consist of 8 additional weeks of high dose prednisone treatment.

Read the detailed description

Minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS) are important causes of idiopathic nephrotic syndrome. First-line treatment with high dose prednisone up to 16 weeks is associated with serious side effects. Especially if treatment continues for more than 8 weeks.

Retrospective studies suggested that Rituximab may be more effective in patients unresponsive to 8 weeks of high dose prednisone. Treatment with rituximab was associated with a higher proportion of patients attaining remission of proteinuria and with fewer side effects.

This will be an open-label, randomized controlled trial which compares continued treatment with high dose prednisone (standard therapy) to treatment with rituximab in patients with an idiopathic nephrotic syndrome due to biopsy proven MCD or FSGS age 18 years or older.

All patients will be treated with high dose prednisone (1 mg/kg/day) for 8 weeks.

Patients can be included in the trial in case of persistent persistent proteinuria ≥ 2 g/ 24 hours or a protein-to-creatinine ratio ≥ 2 g/10mmol (2 g/g) after 8 weeks of treatment with high dose prednisone

Patients either receive 2 doses of Rituximab 375 mg/m2 iv at time 0 and 14 days with termination of prednisone or standard therapy which consist of 8 additional weeks of high dose prednisone treatment. In the Rituximab group, B-cells will be monitored weekly, and if no complete depletion is achieved, additional dose(s) of Rituximab will be given at a weekly interval (maximum of 2 additional doses) until complete B cell depletion.

Expected duration of the follow-up is 12 months, consisting of 9 visits.

Being tested
Rituximab, Prednisone
Keywords
Idiopathic nephrotic syndrome, Minimal change disease, Focal segmental glomerulosclerosis, Rituximab, Randomized clinical trial
Medical subject headings
Nephrosis, Lipoid, Glomerulosclerosis, Focal Segmental

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called Mabthera

    Rituximab: 375 mg/m2 intravenously on day 0 and day 14 B-cells will be monitored weekly, and if no complete depletion is achieved, additional dose(s) of Rituximab will be given at a weekly interval until complete B cell depletion (maximum of 2 additional doses).

  • PrednisoneDrug

    Also called Prednisolone

    Prednisone 1 mg/kg/day (max 80 mg/day) for 8 weeks

Study groups in NCT03298698
Study groupRoleWhat they receive
RituximabExperimentalRituximab: 375 mg/m2 intravenously on day 0 and day 14 B-cells will be monitored weekly, and if no complete depletion is achieved, additional dose(s) of Rituximab will be given at a weekly interval until complete B cell depletion (maximum of 2 additional doses).
Receives: Drug: Rituximab
PrednisoneActive comparatorPrednisone 1 mg/kg/day (max 80 mg/day) for 8 weeks
Receives: Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete remission

    The proportion of patients reaching complete remission defined as proteinuria <0.3 g/day or < 300 mg/g

    Measured: 8 weeks

Secondary outcomes (15)

  1. Partial remission

    The proportion of patients reaching partial remission defined as proteinuria < 3.5 g/24 h or < 3.5 g/g and 50% lower than baseline proteinuria

    Measured: 8 weeks

  2. Late complete or partial remission

    The proportion of patients reaching complete remission defined as proteinuria <0.3 g/day or < 300 mg/g or The proportion of patients reaching partial remission defined as proteinuria < 3.5 g/24 h or < 3500 mg/g and 50% lower than baseline proteinuria

    Measured: 2-12 months

  3. Time to remission

    Time between start of treatment and reaching partial or complete remission

    Measured: 12 months

  4. Time to relapse

    The time between partial or complete remission and relapse (defined as urinary protein excretion to ≥3.5 g/24 h or ≥3.5 g/g creatinine

    Measured: 12 months

  5. Proportion of patients with a relapse

    The proportion of patients with relapse (defined as urinary protein excretion to ≥3.5 g/24 h or ≥3.5 g/g creatinine in patients who had at least attained a partial remission and the time to relapse

    Measured: 12 months

  6. Proportion of patients treated with additional immunosuppressive drugs

    Proportion of patients treated with immunosuppressive drugs other than the assigned treatment with rituximab or prednisolone

    Measured: 12 months

  7. General health assessment

    Difference in general health measured by RAND-36

    Measured: at 2, 6, 9 and 12 months

  8. Quality of life measured with TAAQOL

    Difference in quality of life measured with TNO-academisch Ziekenhuis Leiden Questionnaire for Adult's Health-Difference in Quality of Life

    Measured: at 2, 6, 9 and 12 months

  9. Proportion of patients with adverse events

    The proportion of patients with adverse events. Adverse events graded according to Common Terminology Criteria For Adverse Events (NCI-CTCAE v4.03)

    Measured: at 2 and 12 months

  10. Cost-effectiveness analysis

    Cost-effectiveness will be calculated by dividing the difference in costs by the difference in effectiveness (based on the number of patients in remission) derived from the two groups. The resulting cost-effectiveness ratio will be expressed as costs per one more patient in remission

    Measured: at 2, 6, 9 and 12 months

  11. Cost-utility analysis

    Cost-utility analysis will be calculated by dividing the difference in costs by the difference in Quality Adjusted Life Years (QALY's). QALY's will be derived from the EuroQol-5d-5L questionnaire.

    Measured: at 2, 6, 9 and 12 months

  12. Difference in kidney function

    Difference in creatinine clearance and estimated glomerular filtration rate

    Measured: at 2 and 12 months

  13. Proportion of patients with an increase of baseline serum creatinine ≥ 50%

    The percentage of patients with an increase > 50% of serum creatinine from baseline.

    Measured: at 2 and 12 months

  14. Benefit-risk ratio 1

    Difference in the percentage of remissions (benefit) divided by the difference in adverse events grade 3 or 4, including Serious Adverse Events and Suspected Unexpected Serious Adverse Reaction (risk)

    Measured: at 2 and 12 months

  15. Benefit-risk ratio 2

    Difference in the percentage of remissions (benefit) divided by the difference in the total number of adverse events (risk)

    Measured: at 2 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start22 Aug 2018
  3. Primary completion22 Aug 2021 (estimated)
  4. Study completion22 Jan 2022 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298698
Sponsor's protocol ID
RSRNS17
Status last verified
Aug 2018
First submitted
24 Aug 2017
Last updated
27 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.

    PubMed 35230699

  • Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.

    PubMed 35224732

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab and Prednisone in people with Idiopathic Nephrotic Syndrome and Minimal Change Disease, run by Radboud University Medical Center at 1 site in Netherlands.

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 3 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 27 Aug 2018. 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 Netherlands. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jeroen Deegens, MD,PhD (+31243614761, Jeroen.Deegens@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission (time frame: 8 weeks). 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 NCT03298698, which also lists 2 linked publications.

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 27 Aug 2018.

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