Glomerular DiseaseNCT04987450
Effect of Glucocorticoids on Inflammation and Bone Metabolism in Patients With Glomerular Disease
An observational study of Glomerular Disease, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The aim of the study is to assess the influence of high doses of intravenous corticosteroids on plasma inflammation and bone markers in patients with primary glomerular disease. The study would include 40 patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glomerular Disease
- What is being tested?
- Methylprednisolone, prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2018to 30 Jul 2021
- Phase
- Observational
- 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
Study population: The patients with primary glomerular disease who are diagnosed and hospitalized in Nephrology Department in Łódź.
Who may be able to join
- previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings
- an estimated glomerular filtration rate ≥15 ml/min/1.73m2
- proteinuria ≥2.0 g/24h
Who cannot join
- secondary glomerular disease
- acute kidney injury
- acute or chronic inflammation
- malignancy
- uncontrolled hypertension with systolic blood pressure higher than 160 mmHg
- symptomatic hypotension
- advanced heart failure
- history of non-compliance, dementia or depression
Trial locations and contacts
1 site in 1 country.
Katarzyna Pęczek, Dr contact
Poland1 site, 1 recruiting
- Recruiting
Medical University of Lodz, Poland
Lodz
Ireneusz Staroń, Study Chair, ireneusz.staron@umed.lodz.pl
About this study
Official title: Effect of High-dose Glucocorticoids on Markers of Inflammation and Bone Metabolism in Patients With Primary Glomerular Disease
The aim of the study is to assess the influence of high doses of intravenous corticosteroids on plasma inflammation and bone markers in patients with primary glomerular disease. The study would include 40 patients with chronic kidney disease. The main inclusion criterion is clinical and histopathological diagnosis of primary glomerular disease and urine protein excretion >2.0 g/24h. The exclusion criteria include secondary glomerular disease, acute kidney injury, acute or chronic inflammation, history of non-compliance.
Read the detailed description
Glucocorticoids are one of the most widely used classes of drugs to treat inflammatory and autoimmune diseases. They increase formation of osteoclasts and enhance bone resorption thereby increasing risk of bone fractures and osteoporosis.
Sirtuin-1(SIRT-1) belongs to family of proteins involved in protection against inflammation and oxidative stress. A role of SIRT-1 in regulation of bone metabolism during high-dose steroid therapy is unknown.
The study protocol was approved by the local Bioethics Committee and the study is conducted according to the Declaration of Helsinki. Adult patients with the previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings are included.
Plasma concentration of SIRT-1, interleukin-6 (IL-6), fibroblast growth factor 23 (FGF-23), sclerostin, calcium, phosphate, parathormone (PTH) and urine excretion of total protein, albumin, creatinine, calcium and phosphate are measured at baseline. Then the patients receive three intravenous pulses of methylprednisolone of 500 mg followed by oral prednisone 0.8-1.0 mg/kg/24h. The same measurements are repeated 4, 7 and 30 days after starting the steroid treatment.
- Conditions
- Glomerular Disease
- Being tested
- Methylprednisolone, prednisone
- Keywords
- glucocorticoids, primary glomerular disease, sirtuin-1, sclerostin
- Medical subject headings
- Sclerosteosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone, prednisoneDrug
The patients receive intravenous pulses of methylprednisolone 20-30 mg/kg/day for three consecutive days followed by oral prednisone 0.8-1.0 mg/kg/day.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Plasma levels of SIRT-1, IL-6, FGF-23, sclerostin, calcium, phosphate, PTH and urine excretion of total protein, albumin, creatinine, calcium and phosphate are measured at baseline. Then the patients receive three intravenous daily pulses of methylprednisolone of 500 mg followed by oral prednisone 0.8-1.0 mg/kg/24h. The same measurements are repeated 4, 7 and 30 days after starting the steroid treatment. Receives: Drug: Methylprednisolone, prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of plasma SIRT-1 level after glucocorticoids administration
Measured: 30 days
the change of plasma sclerostin level after glucocorticoids administration
Measured: 30 days
the change of plasma FGF-23 level after glucocorticoids administration
Measured: 30 days
the change of plasma IL-6 level after glucocorticoids administration
Measured: 30 days
the change of plasma total calcium level after glucocorticoids administration
Measured: 30 days
the change of plasma phosphate level after glucocorticoids administration
Measured: 30 days
the change of plasma PTH level after glucocorticoids administration
Measured: 30 days
the change of urine albumin/creatinine ratio after glucocorticoids administration
Measured: 30 days
the change of urine total protein/creatinine ratio after glucocorticoids administration
Measured: 30 days
the change of urine phosphate/creatinine ratio after glucocorticoids administration
Measured: 30 days
the change of urine calcium/creatinine ratio after glucocorticoids administration
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Oct 2018
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerular DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Nowicki, Medical University of Lodz
- Investigators
- Michał Nowicki, Prof. MD., Principal investigator, Department of Nephrology, Hypertension and Kidney Transplantation Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987450
- Sponsor's protocol ID
- RNN/267/17/KE
- Status last verified
- Aug 2021
- First submitted
- 22 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-dose Glucocorticoids on Markers of Inflammation and Bone Metabolism in Patients With Primary Glomerular Disease
- ClinicalTrials.gov ID
- NCT04987450
- Acronym / sponsor ID
- RNN/267/17/KE
- Conditions
- Glomerular Disease
- Keywords
- glucocorticoids, primary glomerular disease, sirtuin-1, sclerostin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 3 Aug 2021 (actual)
- 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.
The aim of the study is to assess the influence of high doses of intravenous corticosteroids on plasma inflammation and bone markers in patients with primary glomerular disease. The study would include 40 patients with chronic kidney disease. The main inclusion criterion is clinical and histopathological diagnosis of primary glomerular disease and urine protein excretion >2.0 g/24h. The exclusion criteria include secondary glomerular disease, acute kidney injury, acute or chronic inflammation, history of non-compliance.
Detailed description
Glucocorticoids are one of the most widely used classes of drugs to treat inflammatory and autoimmune diseases. They increase formation of osteoclasts and enhance bone resorption thereby increasing risk of bone fractures and osteoporosis.
Sirtuin-1(SIRT-1) belongs to family of proteins involved in protection against inflammation and oxidative stress. A role of SIRT-1 in regulation of bone metabolism during high-dose steroid therapy is unknown.
The study protocol was approved by the local Bioethics Committee and the study is conducted according to the Declaration of Helsinki. Adult patients with the previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings are included.
Plasma concentration of SIRT-1, interleukin-6 (IL-6), fibroblast growth factor 23 (FGF-23), sclerostin, calcium, phosphate, parathormone (PTH) and urine excretion of total protein, albumin, creatinine, calcium and phosphate are measured at baseline. Then the patients receive three intravenous pulses of methylprednisolone of 500 mg followed by oral prednisone 0.8-1.0 mg/kg/24h. The same measurements are repeated 4, 7 and 30 days after starting the steroid treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Drug: Methylprednisolone, prednisonePlasma levels of SIRT-1, IL-6, FGF-23, sclerostin, calcium, phosphate, PTH and urine excretion of total protein, albumin, creatinine, calcium and phosphate are measured at baseline. Then the patients receive three intravenous daily pulses of methylprednisolone of 500 mg followed by oral prednisone 0.8-1.0 mg/kg/24h. The same measurements are repeated 4, 7 and 30 days after starting the steroid treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with primary glomerular disease who are diagnosed and hospitalized in Nephrology Department in Łódź.
Key inclusion criteria (3 listed)
- previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings
- an estimated glomerular filtration rate ≥15 ml/min/1.73m2
- proteinuria ≥2.0 g/24h
Key exclusion criteria (8 listed)
- secondary glomerular disease
- acute kidney injury
- acute or chronic inflammation
- malignancy
- uncontrolled hypertension with systolic blood pressure higher than 160 mmHg
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, prednisoneThe patients receive intravenous pulses of methylprednisolone 20-30 mg/kg/day for three consecutive days followed by oral prednisone 0.8-1.0 mg/kg/day. | Drug | Study population |
Primary outcome
the change of plasma SIRT-1 level after glucocorticoids administration
Time frame: 30 days
the change of plasma sclerostin level after glucocorticoids administration
Time frame: 30 days
the change of plasma FGF-23 level after glucocorticoids administration
Time frame: 30 days
the change of plasma IL-6 level after glucocorticoids administration
Time frame: 30 days
the change of plasma total calcium level after glucocorticoids administration
Time frame: 30 days
the change of plasma phosphate level after glucocorticoids administration
Time frame: 30 days
the change of plasma PTH level after glucocorticoids administration
Time frame: 30 days
the change of urine albumin/creatinine ratio after glucocorticoids administration
Time frame: 30 days
the change of urine total protein/creatinine ratio after glucocorticoids administration
Time frame: 30 days
the change of urine phosphate/creatinine ratio after glucocorticoids administration
Time frame: 30 days
the change of urine calcium/creatinine ratio after glucocorticoids administration
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Katarzyna Pęczek, Dr contact
Michał Nowicki, Prof. MD. principal investigator
Department of Nephrology, Hypertension and Kidney Transplantation Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glomerular Disease, run by Medical University of Lodz at 1 site in Poland.
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 8 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 3 Aug 2021. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michał Nowicki, Prof. MD. (+ 48 42 2014400, nefro@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of plasma SIRT-1 level after glucocorticoids administration (time frame: 30 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2021.