A Phase 2 interventional study of stiripentol (Diacomit) in Primary Hyperoxaluria, sponsored by Biocodex. Completed at 3 sites in France. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2021-03-26.
Sponsored by Biocodex · Phase 2, Interventional, and Treatment
Evaluation of the efficacy of stiripentol (Diacomit) as monotherapy for the treatment of primary hyperoxaluria.
Pilot clinical study, open, prospective and multicenter.
42 studies on the registry are indexed under Hyperoxaluria, Primary; 11 are open to participants now.
This study's enrollment of 15 is below the median of 24 across 26 interventional studies indexed under Hyperoxaluria, Primary.
Browse Hyperoxaluria, Primary studies →Biocodex is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: stiripentol (Diacomit)
Administration of stiripentol per os
Relative variation (%) of the molar ratio [oxaluria / creatinuria] between baseline and after two weeks of treatment.
Relative variation (%) of the molar ratio \[oxaluria / creatinuria\] between baseline and after two weeks of treatment.
Time frame: Change (%) of the molar ratio [oxaluria / creatinuria] between the baseline value (average of 3 measures done during pre-treatment period) and the value (average of 2 measures) after 2 weeks of treatment.
Relative variation (%) of the molar ratio [oxaluria / creatinuria] between baseline and after three weeks of treatment.
Relative variation (%) of the molar ratio \[oxaluria / creatinuria\] between baseline and after three weeks of treatment.
Time frame: Change (%) of the molar ratio [oxaluria / creatinuria] between the baseline value (average of 3 measures done during pre-treatment period) and the value (average of 2 measures) after 3 weeks of treatment.
Response to treatment defined by a decrease> 20% of the molar ratio [oxaluria / creatinuria]
Response to treatment defined by a decrease\> 20% of the molar ratio \[oxaluria / creatinuria\]
Time frame: 3 measures from inclusion to first treatment intake (= baseline value), then 2 measures at Day 14 and Day 15 respectively (=value after 2 weeks of treatment), and 2 measures at Day 20 and Day 21 respectively (=value after 3 weeks of treatment)
Relative variation (%) of supersaturation of urine with calcium oxalate between the start and the end of treatment period
Relative variation (%) of supersaturation of urine with calcium oxalate between the start and the end of treatment period
Time frame: 3 measures from inclusion to first treatment intake (= baseline value), then 2 measures at Day 14 and Day 15 respectively (=value after 2 weeks of treatment), and 2 measures at Day 20 and Day 21 respectively (=value after 3 weeks of treatment)
Relative variation (%) in overall crystalline volume measured by crystalluria on fresh urine between the start and the end of treatment period
Relative variation (%) in overall crystalline volume measured by crystalluria on fresh urine between the start and the end of treatment period
Time frame: 3 measures from inclusion to first treatment intake (= baseline value), then 2 measures at Day 14 and Day 15 respectively (=value after 2 weeks of treatment), and 2 measures at Day 20 and Day 21 respectively (=value after 3 weeks of treatment)
Effect of stiripentol dose increase on absolute decrease of the molar ratio [oxaluria / creatinuria]
Effect of stiripentol dose increase on absolute decrease of the molar ratio \[oxaluria / creatinuria\]
Time frame: 3 measures from inclusion to first treatment intake (= baseline value), then 2 measures at Day 14 and Day 15 respectively (=value after 2 weeks of treatment), and 2 measures at Day 20 and Day 21 respectively (=value after 3 weeks of treatment)
Effect of stiripentol dose increase on relative decrease (%) of the molar ratio [oxaluria / creatinuria]
Effect of stiripentol dose increase on relative decrease (%) of the molar ratio \[oxaluria / creatinuria\]
Time frame: 3 measures from inclusion to first treatment intake (= baseline value), then 2 measures at Day 14 and Day 15 respectively (=value after 2 weeks of treatment), and 2 measures at Day 20 and Day 21 respectively (=value after 3 weeks of treatment)
Blood test results (hepatic assessment) at the start and at the end of the study
Blood test results (hepatic assessment) at the start and at the end of the study
Time frame: From start of participation of the patient to end of the treatment period (up to 8 weeks)
Blood test results (blood cells count) at the start and at the end of the study
Blood test results (blood cells count) at the start and at the end of the study
Time frame: From start of participation of the patient to end of the treatment period (up to 8 weeks)
Frequency and nature of the adverse events throughout the study
Frequency and nature of the adverse events throughout the study
Time frame: From start of participation of the patient to end of the treatment period (up to 8 weeks)
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2019 to primary completion in Dec 2020, 18 months.
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Stiripentol
Biocodex