Recent studies show that treatment schedules of the first episode can safely be reduced (Hahn et al., 2015; Hoyer,2015), which may reduce steroid toxicity. The hypothesis of the REducing STEroids in Relapsing Nephroticsyndrome (RESTERN) study is…
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time till first relapse
Secondary outcome
Number of relapses
Development of frequent relapsing nephrotic syndrome
Development of steroid resistant nephrotic syndrome
Total dose of prednisone during the study period.
Background summary
Most children with steroid sensitive nephrotic syndrome experience several
relapses, which are treated with steroids.
For most children, long-term prognosis is for complete resolution of their
disease over time and maintenance of normal
kidney function. It is therefore vital to focus on minimizing adverse events of
the disease and its therapy. Unfortunately,
no randomized controlled trials are available to determine the optimal steroid
treatment of an infrequent relapse of the
nephrotic syndrome.
Study objective
Recent studies show that treatment schedules of the first episode can safely be
reduced (Hahn et al., 2015; Hoyer,
2015), which may reduce steroid toxicity. The hypothesis of the REducing
STEroids in Relapsing Nephrotic
syndrome (RESTERN) study is that a reduction to two weeks of alternate day
steroids after inducing remission is
effective and safe, reduces steroid exposure by 30% on average, and is
therefore preferable.
Study design
Using a double blind, randomized, placebo-controlled trial, this hypothesis
will be tested.
Intervention
for 50 % of the patients a reduction of alternate day steroids to two weeks
after inducing remission
.
Study burden and risks
The subjects randomized to the placebo treatment could possibly have reduced
clinical effects in the treatment of their recurrent nephrotic syndrome by the
prednisone reduction. However, these patients also have a reduced exposure to
prednisone , thereby minimizing the toxicity risks
Geert Grooteplein 10
Nijmegen 6525 GZ
NL
Geert Grooteplein 10
Nijmegen 6525 GZ
NL
Listed location countries
Age
Inclusion criteria
- Age over 1 and less than 18 years;
- Steroid sensitive nephrotic syndrome;
- The last prednisolone use (at a dose over 10 mg/m2 on alternate days) for the
treatment of a previous episode was at least 4 weeks ago;
- Signed informed consent from the parent or legal assent and/or the patient, depending on the age of the patient.
Exclusion criteria
- Steroid resistant nephrotic syndrome;
- Daily prednisone maintenance therapy at any dose;
- Alternate day prednisone maintenance therapy at a dose over 4 mg/m2;
- Documented or suspected significant non-compliance.
- Pregnancy;
- Stimulant drug use;
- Comorbidity;
o Kidney transplant recipient
o Any disease that requires the variation in oral prednisolone to be at the
discretion of the treating physician(s);
- Concomitant use of drugs that induce CYP 3A4: carbamazepine, phenobarbital,
phenytoin and/or rifampicin;
- Concomitant use of drugs that inhibit CYP 3A4: ketaconazole, itraconazole,
ritonavir, indinavir, macrolide antibiotics (erythromycin), diltiazem, verapamil.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002430-76-NL |
| CCMO | NL58185.091.16 |
| OMON | NL-OMON20897 |