Systemic LupusNCT04256577
Serum Ceramides Level in Systemic Lupus Erythematosus (SLE) Patients as a Novel Marker for Renal Impairment
An observational study of Systemic Lupus, run by Assiut University.
Trial summary
1. Estimation of serum ceramides level in SLE patients as anovel marker for renal impairment 2. Correlation serum ceramides level with histological classification of LN,C3,C4,ANA,ANTI DS DNA ,CRP ,ESR , eGFR , creatinine /protein ratio 3. Read more about this study
- Who is it for?
- Ages 17 to 60 years
- Conditions the study is for
- Systemic Lupus
- What is being tested?
- serum ceramides level in blood
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Jun 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 17 to 60 years
- All sexes
- Child, Adult
Study population: Prospective analytic (cross_section) study will be carried out on patients admitted to assiut university hospital internal medicine department.
Who may be able to join
- Forty five patients will SLE with and without renal impairment diagnosed as SLE according to SLICC classification criteria for SLE
Who cannot join
- Malignant tumor ,infectious diseases, Alzheimer disease ,type 2 diabetes mellitus vitamin D intaker, obesty , cardiovascular disease (HTN,HF ,ischemic heart disease)
Trial locations and contacts
No sites are listed yet.
About this study
- Estimation of serum ceramides level in SLE patients as anovel marker for renal impairment
- Correlation serum ceramides level with histological classification of LN,C3,C4,ANA,ANTI DS DNA ,CRP ,ESR , eGFR , creatinine /protein ratio
- Follow up estimation of ceramides level in LN patients after 3 cycles of treatment
Read the detailed description
Systemic lupus erythrematosus (SLE) is an autoimmune disease with increasing prevalence and incidence , The clinical manifestation is multifaceted and targets the musculoskeletal system, the skin and different organs like lung and kidney From 30-80% of SLE patients develop lupus nephritis (LN) which often leads to chronic kidney disease (CKD) and end-stage renal disease (ESRD) and is associated with an overall poor prognosis and high mortality Diagnosis of LN is made by kidney biopsy, which still remains the gold standard Histological evaluation distinguish between different stages of LN upon morphological changes within the kidney . However, noninvasive methods to diagnose and guide LN therapy are currently not established in the clinic. On the other hand, an early diagnosis is important for the therapeutic success and thereby lowers the risk of ESRD In this context, classical clinical markers for renal dysfunction are insufficient for an early assessment of the need for renal biopsies and subsequently to decide about the optimal therapy. Even though traditional biomarkers like antids DNA antibodies and complement deficiency are widely accepted as diagnostic instruments to assess disease activity, their specificity is rather low, and they appear to be more suitable to confirm diagnosis of SLE and LN in an already likely clinical setting Ceramides are a family of waxy lipid molecules ,composed of sphingosine and fatty acide ,found in high concentration with in the cell membrane of eukaryocyte cells, since they are component lipids that make up sphingomyelin, one of the major lipids in the lipid bilayer Ceramides and other sphingolipids found in cell membrane were purely supporting structural elements,also participate in variety of cellular signaling, regulating differentiation, proliferation, Programmed cell death(PCD) Sphingolipids are a heterogenous group of lipids with more than 400 single compounds formed by structural and chemical modifications of a sphingosine backbone Recent studies reveal that blood sphingolipids not only have important signaling properties but also serve as biomarkers in various renal disease Patyna etal in 2019 concluded that ceramides in blood could act as potent biomarker for renal impairment in patient
- Conditions
- Systemic Lupus
- Being tested
- serum ceramides level in blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum ceramides level in bloodDiagnostic test
Serum ceramides ( sphingolipid measurement, plasma (EDTA as anticoagulant) and serum separation was performed immediately after blood drawing by two-time scentrifugation at 750 x g for 5 min (4°C). Lipid extraction from plasma and/or serum samples (10 µl each) and subsequent LC-MS/MS)
| Study group | Role | What they receive |
|---|---|---|
| patients proven having (SLE) | 20 patients proven to have systemic lupus Erthematosus without renal impairment (eGFR) ≥ 80 ml/min/1.73 m2 and albumin / creatinine ≤ 30 mg/g) Receives: Diagnostic Test: serum ceramides level in blood | |
| patients proven to have (LN) by renal biopsy | Group (2) 25 patients proven to have LN by renal biopsy before starting treatment and after 3 cycle of treatment (eGFR < 80 ml/min/1.73 m2 and albumin/creatinine ratio > 30 mg/g) Receives: Diagnostic Test: serum ceramides level in blood | |
| healthy control | (20) patients healthy control matched in age and sex Receives: Diagnostic Test: serum ceramides level in blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of serum ceramides level in SLE patients as anovel marker for renal impairment
Correlation serum ceramides level with histological classification of LN,C3,C4,ANA,ANTI DS DNA ,CRP ,ESR , eGFR , creatinine /protein ratio
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionJun 2021 (estimated)
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 Systemic LupusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NADIA HUSSIEN HAMMAM HUSSIEN, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256577
- Sponsor's protocol ID
- serum ceramides level in (SLE)
- Status last verified
- Jan 2020
- First submitted
- 3 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patyna S, Buttner S, Eckes T, Obermuller N, Bartel C, Braner A, Trautmann S, Thomas D, Geiger H, Pfeilschifter J, Koch A. Blood ceramides as novel markers for renal impairment in systemic lupus erythematosus. Prostaglandins Other Lipid Mediat. 2019 Oct;144:106348. doi: 10.1016/j.prostaglandins.2019.106348. Epub 2019 Jul 10.
PubMed 31301404
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Ceramides Level in Systemic Lupus Erythematosus (SLE) Patients as a Novel Marker for Renal Impairment
- ClinicalTrials.gov ID
- NCT04256577
- Acronym / sponsor ID
- serum ceramides level in (SLE)
- Conditions
- Systemic Lupus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 5 Feb 2020 (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.
- Estimation of serum ceramides level in SLE patients as anovel marker for renal impairment
- Correlation serum ceramides level with histological classification of LN,C3,C4,ANA,ANTI DS DNA ,CRP ,ESR , eGFR , creatinine /protein ratio
- Follow up estimation of ceramides level in LN patients after 3 cycles of treatment
Detailed description
Systemic lupus erythrematosus (SLE) is an autoimmune disease with increasing prevalence and incidence , The clinical manifestation is multifaceted and targets the musculoskeletal system, the skin and different organs like lung and kidney From 30-80% of SLE patients develop lupus nephritis (LN) which often leads to chronic kidney disease (CKD) and end-stage renal disease (ESRD) and is associated with an overall poor prognosis and high mortality Diagnosis of LN is made by kidney biopsy, which still remains the gold standard Histological evaluation distinguish between different stages of LN upon morphological changes within the kidney . However, noninvasive methods to diagnose and guide LN therapy are currently not established in the clinic. On the other hand, an early diagnosis is important for the therapeutic success and thereby lowers the risk of ESRD In this context, classical clinical markers for renal dysfunction are insufficient for an early assessment of the need for renal biopsies and subsequently to decide about the optimal therapy. Even though traditional biomarkers like antids DNA antibodies and complement deficiency are widely accepted as diagnostic instruments to assess disease activity, their specificity is rather low, and they appear to be more suitable to confirm diagnosis of SLE and LN in an already likely clinical setting Ceramides are a family of waxy lipid molecules ,composed of sphingosine and fatty acide ,found in high concentration with in the cell membrane of eukaryocyte cells, since they are component lipids that make up sphingomyelin, one of the major lipids in the lipid bilayer Ceramides and other sphingolipids found in cell membrane were purely supporting structural elements,also participate in variety of cellular signaling, regulating differentiation, proliferation, Programmed cell death(PCD) Sphingolipids are a heterogenous group of lipids with more than 400 single compounds formed by structural and chemical modifications of a sphingosine backbone Recent studies reveal that blood sphingolipids not only have important signaling properties but also serve as biomarkers in various renal disease Patyna etal in 2019 concluded that ceramides in blood could act as potent biomarker for renal impairment in patient
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients proven having (SLE) | – | Diagnostic Test: serum ceramides level in blood20 patients proven to have systemic lupus Erthematosus without renal impairment (eGFR) ≥ 80 ml/min/1.73 m2 and albumin / creatinine ≤ 30 mg/g) |
| patients proven to have (LN) by renal biopsy | – | Diagnostic Test: serum ceramides level in bloodGroup (2) 25 patients proven to have LN by renal biopsy before starting treatment and after 3 cycle of treatment (eGFR < 80 ml/min/1.73 m2 and albumin/creatinine ratio > 30 mg/g) |
| healthy control | – | Diagnostic Test: serum ceramides level in blood(20) patients healthy control matched in age and sex |
Who may qualify
- Ages
- 17 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Prospective analytic (cross_section) study will be carried out on patients admitted to assiut university hospital internal medicine department.
Key inclusion criteria (1 listed)
- Forty five patients will SLE with and without renal impairment diagnosed as SLE according to SLICC classification criteria for SLE
Key exclusion criteria (1 listed)
- Malignant tumor ,infectious diseases, Alzheimer disease ,type 2 diabetes mellitus vitamin D intaker, obesty , cardiovascular disease (HTN,HF ,ischemic heart disease)
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 |
|---|---|---|
| serum ceramides level in bloodSerum ceramides ( sphingolipid measurement, plasma (EDTA as anticoagulant) and serum separation was performed immediately after blood drawing by two-time scentrifugation at 750 x g for 5 min (4°C). Lipid extraction from plasma and/or serum samples (10 µl each) and subsequent LC-MS/MS) | Diagnostic test | healthy control, patients proven having (SLE), patients proven to have (LN) by renal biopsy |
Primary outcome
Estimation of serum ceramides level in SLE patients as anovel marker for renal impairment
Time frame: base line
Correlation serum ceramides level with histological classification of LN,C3,C4,ANA,ANTI DS DNA ,CRP ,ESR , eGFR , creatinine /protein ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Background: PubMed 31301404Patyna S, Buttner S, Eckes T, Obermuller N, Bartel C, Braner A, Trautmann S, Thomas D, Geiger H, Pfeilschifter J, Koch A. Blood ceramides as novel markers for renal impairment in systemic lupus erythematosus. Prostaglandins Other Lipid Mediat. 2019 Oct;144:106348. doi: 10.1016/j.prostaglandins.2019.106348. Epub 2019 Jul 10.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus, run by Assiut University.
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 1 inclusion and 1 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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 nadia hussien hammam, Resident doctor (01006912253, dr.nadia_hussien@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of serum ceramides level in SLE patients as anovel marker for renal impairment (time frame: base line). 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 NCT04256577, 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 17 Feb 2020.