Renal SarcoidosisCORTICOIDOSENCT01652417
Treatment of Renal Sarcoidosis by Methylprednisolone Bolus
A study testing methylprednisolone bolus IV 15 mg/kg/d for 3 days. in people with Renal Sarcoidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Renal sarcoidosis treatment is based on steroids, but the dose and duration are unknown. Despite this treatment, most patients will have chronic kidney disease. From our previous studies, the investigators believe that high dose steroids by methylprednisolone bolus will improve patient outcome and renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Sarcoidosis
- What is being tested?
- methylprednisolone bolus IV 15 mg/kg/d for 3 days.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Nov 2015
- Phase
- Interventional
- 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
- Acute kidney injury with estimated glomerular filtration rate (eGFR) < 60 mL/min/1,73 m2, defined by an increase of initial value > 25% or an increase of > 30 µmol/l, since at least 3 months.
- Sarcoidosis diagnostic criteria according to ATS/ERS/WASOG (Am J Respir Crit Care Med 1999)
- Renal biopsy compatible with renal sarcoidosis :
- Granulomatosis tubulo-interstitial nephropathy and extra-renal damage of histologically proved or suggestive sarcoidosis Or
- Tubulo-interstitial nephropathy without granuloma and extra-renal damage of histologically proved sarcoidosis
- Informed consent
- Patients with social security
Who cannot join
- Corticosteroids greater than 0,25 mg/kg/j prednisone equivalent
- Introduction of an immunosuppressant in the month before inclusion
- Another cause of renal granulomatosis or tubulo-interstitial nephropathy
- Isolated renal damage without extra-renal past or present damage for a sarcoidosis
- Chronic renal failure, prior sarcoidosis with eGFR < 30 mL/min/1,73 m2
- Acute renal failure from other causes. If hypercalcaemia is greater than 3 mmol/L, the correction of any dehydration will systematically salt intake, followed of renal function control before inclusion.
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- Pregnancy, nursing
- Tuberculosis
- Uncontrolled sepsis
- Uncontrolled psychotic state
- Hypersensibility to methylprednisolone hemisuccinate
- Drugs prescription causing wave burst arrhythmia and/or long QT on ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis
Renal sarcoidosis treatment is based on steroids, but the dose and duration are unknown. Despite this treatment, most patients will have chronic kidney disease. From our previous studies, the investigators believe that high dose steroids by methylprednisolone bolus will improve patient outcome and renal function.
Read the detailed description
In a multicentric, randomized, open trial, the investigators will assess the efficacy of methylprednisolone bolus at 15mg/kg/d for 3 days before oral steroids on renal function improvement in renal sarcoidosis patients.
- Conditions
- Renal Sarcoidosis
- Being tested
- methylprednisolone bolus IV 15 mg/kg/d for 3 days.
- Keywords
- Methylprednisolone, prednisone, renal sarcoidosis treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylprednisolone bolus IV 15 mg/kg/d for 3 days.Drug
Also called Methylprenisolone Mylan
methylprednisolone bolus IV 15 mg/kg/d for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| oral prednisone | No intervention | Oral prednisone 1 mg/kg/d for 30 days and progressive tapering of steroids, to get 0,5 mg/kg/d at M3 and 0,25 mg/kg/d at M6 and 5-10 mg at M12. |
| methylprednisolone bolus | Experimental | methylprednisolone bolus 15 mg/kg/d for 3 days before oral prednisone 1 mg/kg/d for 30 days and progressive tapering of steroids, to get 0,5 mg/kg/d at M3 and 0,25 mg/kg/d at M6 and 5-10 mg at M12. Receives: Drug: methylprednisolone bolus IV 15 mg/kg/d for 3 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a positive response defined by eGRF better than 100% compared to eGRF prior treatment or a normalization of renal function.
Measured: 3 months after the beginning of the treatment
Secondary outcomes (7)
Efficacy (eGFR, percentage of patients with a eGRF < 60 ml/min/1.73m²)
Measured: 1, 3, 6 and 12 months after the beginning of the treatment
Extra-renal manifestations
Measured: 1, 3, 6 and 12 months after the beginning of the treatment
incidence of arrhythmias and cardiac conduction disease
Measured: 1, 3, 6 and 12 months after the beginning of the treatment
fragility fracture
Measured: 1, 3, 6 and 12 months after the beginning of the treatment
neuro-psychiatric troubles and infections
Measured: 1, 3, 6 and 12 months after the beginning of the treatment
number of renal and extra-renal relapses.
Measured: 1, 3, 6 and 12 months after the beginning of the treatment
Characterization of vitamin and calcium deficiencies by blood and urinary dosages
Measured: 1, 3, 6 and 12 months after the beginning of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal SarcoidosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652417
- Sponsor's protocol ID
- P 110118
- Other IDs
- AOM 11003
- Acronym
- CORTICOIDOSE
- Status last verified
- Oct 2015
- First submitted
- 16 May 2012
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mahevas M, Audard V, Rousseau A, Cez A, Guerrot D, Verhelst D, Delahousse M, Hanrotel C, Pillebout E, Daugas E, Krastinova E, Valeyre D, Boffa JJ; GSF French Sarcoidosis Group. Efficacy and safety of methylprednisolone pulse followed by oral prednisone vs. oral prednisone alone in sarcoidosis tubulointerstitial nephritis: a randomized, open-label, controlled clinical trial. Nephrol Dial Transplant. 2023 Mar 31;38(4):961-968. doi: 10.1093/ndt/gfac227.
PubMed 36066903
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis
- ClinicalTrials.gov ID
- NCT01652417
- Acronym / sponsor ID
- CORTICOIDOSE / P 110118
- Conditions
- Renal Sarcoidosis
- Keywords
- Methylprednisolone, prednisone, renal sarcoidosis treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Renal sarcoidosis treatment is based on steroids, but the dose and duration are unknown. Despite this treatment, most patients will have chronic kidney disease. From our previous studies, the investigators believe that high dose steroids by methylprednisolone bolus will improve patient outcome and renal function.
Detailed description
In a multicentric, randomized, open trial, the investigators will assess the efficacy of methylprednisolone bolus at 15mg/kg/d for 3 days before oral steroids on renal function improvement in renal sarcoidosis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral prednisone | No intervention | –Oral prednisone 1 mg/kg/d for 30 days and progressive tapering of steroids, to get 0,5 mg/kg/d at M3 and 0,25 mg/kg/d at M6 and 5-10 mg at M12. |
| methylprednisolone bolus | Experimental | Drug: methylprednisolone bolus IV 15 mg/kg/d for 3 days.methylprednisolone bolus 15 mg/kg/d for 3 days before oral prednisone 1 mg/kg/d for 30 days and progressive tapering of steroids, to get 0,5 mg/kg/d at M3 and 0,25 mg/kg/d at M6 and 5-10 mg at M12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Acute kidney injury with estimated glomerular filtration rate (eGFR) < 60 mL/min/1,73 m2, defined by an increase of initial value > 25% or an increase of > 30 µmol/l, since at least 3 months.
- Sarcoidosis diagnostic criteria according to ATS/ERS/WASOG (Am J Respir Crit Care Med 1999)
- Renal biopsy compatible with renal sarcoidosis :
- Granulomatosis tubulo-interstitial nephropathy and extra-renal damage of histologically proved or suggestive sarcoidosis Or
Key exclusion criteria (12 listed)
- Corticosteroids greater than 0,25 mg/kg/j prednisone equivalent
- Introduction of an immunosuppressant in the month before inclusion
- Another cause of renal granulomatosis or tubulo-interstitial nephropathy
- Isolated renal damage without extra-renal past or present damage for a sarcoidosis
- Chronic renal failure, prior sarcoidosis with eGFR < 30 mL/min/1,73 m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylprednisolone bolus IV 15 mg/kg/d for 3 days.Also: Methylprenisolone Mylanmethylprednisolone bolus IV 15 mg/kg/d for 3 days. | Drug | methylprednisolone bolus |
Primary outcome
Percentage of patients with a positive response defined by eGRF better than 100% compared to eGRF prior treatment or a normalization of renal function.
Time frame: 3 months after the beginning of the treatment
7 secondary outcomes
Efficacy (eGFR, percentage of patients with a eGRF < 60 ml/min/1.73m²)
Time frame: 1, 3, 6 and 12 months after the beginning of the treatment
Extra-renal manifestations
Time frame: 1, 3, 6 and 12 months after the beginning of the treatment
incidence of arrhythmias and cardiac conduction disease
Time frame: 1, 3, 6 and 12 months after the beginning of the treatment
fragility fracture
Time frame: 1, 3, 6 and 12 months after the beginning of the treatment
neuro-psychiatric troubles and infections
Time frame: 1, 3, 6 and 12 months after the beginning of the treatment
number of renal and extra-renal relapses.
Time frame: 1, 3, 6 and 12 months after the beginning of the treatment
Characterization of vitamin and calcium deficiencies by blood and urinary dosages
Time frame: 1, 3, 6 and 12 months after the beginning of the treatment
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Derived from this study: PubMed 36066903Mahevas M, Audard V, Rousseau A, Cez A, Guerrot D, Verhelst D, Delahousse M, Hanrotel C, Pillebout E, Daugas E, Krastinova E, Valeyre D, Boffa JJ; GSF French Sarcoidosis Group. Efficacy and safety of methylprednisolone pulse followed by oral prednisone vs. oral prednisone alone in sarcoidosis tubulointerstitial nephritis: a randomized, open-label, controlled clinical trial. Nephrol Dial Transplant. 2023 Mar 31;38(4):961-968. doi: 10.1093/ndt/gfac227.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylprednisolone bolus IV 15 mg/kg/d for 3 days. in people with Renal Sarcoidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 25 Feb 2016. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with a positive response defined by eGRF better than 100% compared to eGRF prior treatment or a normalization of renal function. (time frame: 3 months after the beginning of the treatment). 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 NCT01652417, which also lists 1 linked publication.
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 25 Feb 2016.