Lupus NephritisNCT07505576
Anti-alpha-actinin Antibodies and Lupus Nephritis Activity
An observational study of Lupus Nephritis, run by Assiut University.
Trial summary
Lupus nephritis (LN) develops in 30-60% of systemic lupus erythematosus (SLE) patients and remains a leading cause of morbidity, with 10-30% progressing to end-stage renal disease within 15 years. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- renal biopsy, serum anti-alpha-actinin antibodies and CBC, serum creatinine and urea, estimated GFR, ESR, CRP, urine analysis, ANA, anti dsDNA, C3 & C4, serum albumin, 24-hrs urinary protein, and U. ACR
- Type of treatment
- Injection or infusion
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 1. Inclusion criteria for LN group: 1. Adult patients (≥ 18 and > 60 years) of either sex. 2. Fulfill the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus (SLE) [11]. 3. Diagnosis of active lupus nephritis requiring a renal biopsy as per standard clinical indications (e.g., proteinuria ≥ 0.5 g/24h, active urinary sediment, unexplained rise in serum creatinine). 2. Exclusion criteria: Participants will be excluded if ANY of the following criteria apply: 1. Other Kidney Diseases: * Presence of, or suspicion of, any other primary or significant secondary kidney disease unrelated to SLE (e.g., diabetic nephropathy, hypertensive nephrosclerosis, IgA nephropathy, significant drug-induced nephrotoxicity, rheumatoid arthritis, positive HBs antigen or HCV antibody). 2. Confounding Clinical Conditions: * Presence of an active or recent major infection (e.g., sepsis, pneumonia, UTI) at the time of enrollment, as infection can significantly alter immune markers.
Who may be able to join
- Inclusion criteria for LN group:
- Adult patients (≥ 18 and > 60 years) of either sex.
- Fulfill the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus (SLE).
- Diagnosis of active lupus nephritis requiring a renal biopsy as per standard clinical indications (e.g., proteinuria ≥ 0.5 g/24h, active urinary sediment, unexplained rise in serum creatinine).
- Availability of an adequate renal biopsy specimen for histopathological evaluation according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2018 classification.
- Renal biopsy performed within 3 months prior to enrollment, and patient has not received induction immunosuppressive therapy (cyclophosphamide, mycophenolate mofetil, or calcineurin inhibitors) in the period between biopsy and enrollment.
Show all 11Show fewer
- Provision of written informed consent.
- b)Inclusion Criteria for Control Groups:
- <!-- -->
- SLE without nephritis: Patients meeting SLE criteria without any clinical or laboratory evidence of renal involvement (normal urinalysis, proteinuria < 0.3 g/24h, normal serum creatinine).
- Healthy controls: Age- and sex-matched healthy individuals with no history of autoimmune disease, normal urinalysis, and negative autoantibodies (ANA, anti-dsDNA).
Who cannot join
- -
- Participants will be excluded if ANY of the following criteria apply:
- <!-- -->
- Other Kidney Diseases:
- Presence of, or suspicion of, any other primary or significant secondary kidney disease unrelated to SLE (e.g., diabetic nephropathy, hypertensive nephrosclerosis, IgA nephropathy, significant drug-induced nephrotoxicity, rheumatoid arthritis, positive HBs antigen or HCV antibody).
- Confounding Clinical Conditions:
Show all 11Show fewer
- Presence of an active or recent major infection (e.g., sepsis, pneumonia, UTI) at the time of enrollment, as infection can significantly alter immune markers.
- Presence of advanced chronic kidney disease (CKD Stage 4 or 5) predating the diagnosis of SLE.
- Pregnancy or lactation.
- Confounding Medications:
- Receipt of high-dose corticosteroids (> 20 mg/day of prednisone or equivalent) or any potent immunosuppressive agent (e.g., cyclophosphamide, mycophenolate mofetil, rituximab) within 4 weeks prior to the renal biopsy and blood sampling).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Serum Anti-alpha-actinin Antibodies as an Early Biomarker for Histological Activity in Lupus Nephritis and Its Correlation With Other Conventional Serological Markers
Lupus nephritis (LN) develops in 30-60% of systemic lupus erythematosus (SLE) patients and remains a leading cause of morbidity, with 10-30% progressing to end-stage renal disease within 15 years. The International Society of Nephrology/Renal Pathology Society (ISN/RPS) classifies LN histologically, with proliferative forms (Classes III/IV) carrying the poorest prognosis.
Read the detailed description
Current monitoring tools have significant limitations. Conventional markers (anti-dsDNA, C3/C4) correlate imperfectly with renal activity, as 20-30% of active LN patients have normal anti-dsDNA levels. Renal biopsy remains the gold standard for assessing histological activity through the NIH activity index, but is invasive and cannot be repeated frequently.
Anti-alpha-actinin-4 antibodies have emerged as promising biomarkers. Alpha-actinin-4 is a podocyte cytoskeletal protein critical for glomerular filtration barrier integrity. A subset of anti-dsDNA antibodies cross-reacts with alpha-actinin, directly linking systemic autoimmunity to renal injury. These antibodies induce podocyte damage, complement activation, and correlate with proteinuria and histological activity.
However, comprehensive evaluation of their correlation with detailed histopathological activity indices remains limited, particularly in understudied populations. This study aims to assess the relationship between serum anti-alpha-actinin antibodies and the renal histopathological activity index in LN patients, comparing their performance with conventional serological markers.
- Conditions
- Lupus Nephritis
- Being tested
- renal biopsy, serum anti-alpha-actinin antibodies, CBC, serum creatinine and urea, estimated GFR, ESR, CRP, urine analysis, ANA, anti dsDNA, C3 & C4, serum albumin, 24-hrs urinary protein, and U. ACR
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal biopsyOther
Renal biopsy specimens will be evaluated by light microscopy and will be pathologically classified according to the 2003 International Society of Nephrology/ Renal Pathology Society classification (ISN/RPS Classification) as minimal mesangial (class I), mesangial proliferative LN (class II), focal LN (class III), diffuse LN (class IV), membranous LN (class V) and advanced sclerosis (class VI)
serum anti-alpha-actinin antibodiesDiagnostic test
Serum sample should be collected into a serum separator tube. After clotting for 2 hours at room temperature or overnight at 4°C, and then centrifuging at 1000 × g for 20 minutes. Assay freshly prepared serum immediately or store samples in aliquot at -20°C or -80°C for later use. Avoid repeated freeze-thaw cycles.
CBC, serum creatinine and urea, estimated GFR, ESR, CRP, urine analysis, ANA, anti dsDNA, C3 & C4, serum albumin, 24-hrs urinary protein, and U. ACRDiagnostic test
Laboratory tests including, complete blood count (CBC, serum creatinine and urea and estimated GFR according to CKD-EPI and KDIGO;2024, urine analysis, C-reactive protein (CRP), Erythrocyte Sedimination Rate (ESR), anti-nuclear antibodies (ANA), serum albumin, serum complement (C3 and C4) ,anti-double stranded deoxyribonucleic acid (anti-dsDNA), 24-hrs urinary protein and urinary albumin:creatinine ratio (U. ACR).
| Study group | Role | What they receive |
|---|---|---|
| LN group | 1. Adult patients (≥ 18 and > 60 years) of either sex.
2. Fulfill the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus (SLE) [11].
3. Diagnosis of active lupus nephritis requiring a renal biopsy as per standard clinical indications (e.g., proteinuria ≥ 0.5 g/24h, active urinary sediment, unexplained rise in serum creatinine).
4. Availability of an adequate renal biopsy specimen for histopathological evaluation according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2018 classification.
5. Renal biopsy performed within 3 months prior to enrollment, and patient has not received induction immunosuppressive therapy (cyclophosphamide, mycophenolate mofetil, or calcineurin inhibitors) in the period between biopsy and enrollment.
6. Provision of written informed consent. Receives: Other: renal biopsy; Diagnostic Test: serum anti-alpha-actinin antibodies; Diagnostic Test: CBC, serum creatinine and urea, estimated GFR, ESR, CRP, urine analysis, ANA, anti dsDNA, C3 & C4, serum albumin, 24-hrs urinary protein, and U. ACR | |
| SLE without nephritis | Patients meeting SLE criteria without any clinical or laboratory evidence of renal involvement (normal urinalysis, proteinuria < 0.3 g/24h, normal serum creatinine). Receives: Diagnostic Test: serum anti-alpha-actinin antibodies; Diagnostic Test: CBC, serum creatinine and urea, estimated GFR, ESR, CRP, urine analysis, ANA, anti dsDNA, C3 & C4, serum albumin, 24-hrs urinary protein, and U. ACR | |
| Healthy controls | Age- and sex-matched healthy individuals with no history of autoimmune disease, normal urinalysis, and negative autoantibodies (ANA, anti-dsDNA). Receives: Diagnostic Test: serum anti-alpha-actinin antibodies; Diagnostic Test: CBC, serum creatinine and urea, estimated GFR, ESR, CRP, urine analysis, ANA, anti dsDNA, C3 & C4, serum albumin, 24-hrs urinary protein, and U. ACR |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate associations between anti-alpha-actinin antibody levels and specific histological features of active LN
To evaluate associations between anti-alpha-actinin antibody levels and specific histological features of active LN, including endocapillary hypercellularity, fibrinoid necrosis, and cellular crescents.
Measured: 36 months
measure serum anti-alpha-actinin antibody levels in patients with biopsy-proven active lupus nephritis
To measure serum anti-alpha-actinin antibody levels in patients with biopsy-proven active lupus nephritis and assess their correlation with the NIH histopathological activity index.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Aboelfatouh Tantawy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505576
- Sponsor's protocol ID
- AAALN
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Deocharan B, Qing X, Lichauco J, Putterman C. Alpha-actinin is a cross-reactive renal target for pathogenic anti-DNA antibodies. J Immunol. 2002 Mar 15;168(6):3072-8. doi: 10.4049/jimmunol.168.6.3072.
PubMed 11884481Tsai CY, Li KJ, Shen CY, Lu CH, Lee HT, Wu TH, Ng YY, Tsao YP, Hsieh SC, Yu CL. Decipher the Immunopathological Mechanisms and Set Up Potential Therapeutic Strategies for Patients with Lupus Nephritis. Int J Mol Sci. 2023 Jun 13;24(12):10066. doi: 10.3390/ijms241210066.
PubMed 37373215He S, Zhang J, Wang X, Qi Z, Zhou Z, Wang Y, Xu S, Li D, Ye X, Liu Z, Hao X, Zhao Y, Wang R. Organoid Modeling and Single-Cell Profiling Reveal Smooth Muscle Cell Migration in Moyamoya Disease. Commun Biol. 2026 Jan 7;9(1):198. doi: 10.1038/s42003-025-09476-9.
PubMed 41501150Aringer M. EULAR/ACR classification criteria for SLE. Semin Arthritis Rheum. 2019 Dec;49(3S):S14-S17. doi: 10.1016/j.semarthrit.2019.09.009.
PubMed 31779843Alduraibi FK, Tsokos GC. Lupus Nephritis Biomarkers: A Critical Review. Int J Mol Sci. 2024 Jan 9;25(2):805. doi: 10.3390/ijms25020805.
PubMed 38255879Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
PubMed 11838846Almaani S, Meara A, Rovin BH. Update on Lupus Nephritis. Clin J Am Soc Nephrol. 2017 May 8;12(5):825-835. doi: 10.2215/CJN.05780616. Epub 2016 Nov 7.
PubMed 27821390
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Anti-alpha-actinin Antibodies as an Early Biomarker for Histological Activity in Lupus Nephritis and Its Correlation With Other Conventional Serological Markers
- ClinicalTrials.gov ID
- NCT07505576
- Acronym / sponsor ID
- AAALN
- Conditions
- Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 1 Apr 2026 (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.
Lupus nephritis (LN) develops in 30-60% of systemic lupus erythematosus (SLE) patients and remains a leading cause of morbidity, with 10-30% progressing to end-stage renal disease within 15 years. The International Society of Nephrology/Renal Pathology Society (ISN/RPS) classifies LN histologically, with proliferative forms (Classes III/IV) carrying the poorest prognosis.
Detailed description
Current monitoring tools have significant limitations. Conventional markers (anti-dsDNA, C3/C4) correlate imperfectly with renal activity, as 20-30% of active LN patients have normal anti-dsDNA levels. Renal biopsy remains the gold standard for assessing histological activity through the NIH activity index, but is invasive and cannot be repeated frequently.
Anti-alpha-actinin-4 antibodies have emerged as promising biomarkers. Alpha-actinin-4 is a podocyte cytoskeletal protein critical for glomerular filtration barrier integrity. A subset of anti-dsDNA antibodies cross-reacts with alpha-actinin, directly linking systemic autoimmunity to renal injury. These antibodies induce podocyte damage, complement activation, and correlate with proteinuria and histological activity.
However, comprehensive evaluation of their correlation with detailed histopathological activity indices remains limited, particularly in understudied populations. This study aims to assess the relationship between serum anti-alpha-actinin antibodies and the renal histopathological activity index in LN patients, comparing their performance with conventional serological markers.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LN group | – | Other: renal biopsy, Diagnostic Test: serum anti-alpha-actinin antibodies, Diagnostic Test: CBC, serum creatinine and urea, estimated GFR, ESR, CRP, urine analysis, ANA, anti dsDNA, C3 & C4, serum albumin, 24-hrs urinary protein, and U. ACR1. Adult patients (≥ 18 and > 60 years) of either sex. 2. Fulfill the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus (SLE) [11]. 3. Diagnosis of active lupus nephritis requiring a renal biopsy as per standard clinical indications (e.g., proteinuria ≥ 0.5 g/24h, active urinary sediment, unexplained rise in serum creatinine). 4. Availability of an adequate renal biopsy specimen for histopathological evaluation according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2018 classification. 5. Renal biopsy performed within 3 months prior to enrollment, and patient has not received induction immunosuppressive therapy (cyclophosphamide, mycophenolate mofetil, or calcineurin inhibitors) in the period between biopsy and enrollment. 6. Provision of written informed consent. |
| SLE without nephritis | – | Diagnostic Test: serum anti-alpha-actinin antibodies, Diagnostic Test: CBC, serum creatinine and urea, estimated GFR, ESR, CRP, urine analysis, ANA, anti dsDNA, C3 & C4, serum albumin, 24-hrs urinary protein, and U. ACRPatients meeting SLE criteria without any clinical or laboratory evidence of renal involvement (normal urinalysis, proteinuria < 0.3 g/24h, normal serum creatinine). |
| Healthy controls | – | Diagnostic Test: serum anti-alpha-actinin antibodies, Diagnostic Test: CBC, serum creatinine and urea, estimated GFR, ESR, CRP, urine analysis, ANA, anti dsDNA, C3 & C4, serum albumin, 24-hrs urinary protein, and U. ACRAge- and sex-matched healthy individuals with no history of autoimmune disease, normal urinalysis, and negative autoantibodies (ANA, anti-dsDNA). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. Inclusion criteria for LN group: 1. Adult patients (≥ 18 and > 60 years) of either sex. 2. Fulfill the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus (SLE) [11]. 3. Diagnosis of active lupus nephritis requiring a renal biopsy as per standard clinical indications (e.g., proteinuria ≥ 0.5 g/24h, active urinary sediment, unexplained rise in serum creatinine). 2. Exclusion criteria: Participants will be excluded if ANY of the following criteria apply: 1. Other Kidney Diseases: * Presence of, or suspicion of, any other primary or significant secondary kidney disease unrelated to SLE (e.g., diabetic nephropathy, hypertensive nephrosclerosis, IgA nephropathy, significant drug-induced nephrotoxicity, rheumatoid arthritis, positive HBs antigen or HCV antibody). 2. Confounding Clinical Conditions: * Presence of an active or recent major infection (e.g., sepsis, pneumonia, UTI) at the time of enrollment, as infection can significantly alter immune markers.
Key inclusion criteria (11 listed)
- Inclusion criteria for LN group:
- <!-- -->
Key exclusion criteria (11 listed)
- -
- <!-- -->
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 |
|---|---|---|
| renal biopsyRenal biopsy specimens will be evaluated by light microscopy and will be pathologically classified according to the 2003 International Society of Nephrology/ Renal Pathology Society classification (ISN/RPS Classification) as minimal mesangial (class I), mesangial proliferative LN (class II), focal LN (class III), diffuse LN (class IV), membranous LN (class V) and advanced sclerosis (class VI) | Other | LN group |
| serum anti-alpha-actinin antibodiesSerum sample should be collected into a serum separator tube. After clotting for 2 hours at room temperature or overnight at 4°C, and then centrifuging at 1000 × g for 20 minutes. Assay freshly prepared serum immediately or store samples in aliquot at -20°C or -80°C for later use. Avoid repeated freeze-thaw cycles. | Diagnostic test | Healthy controls, LN group, SLE without nephritis |
| CBC, serum creatinine and urea, estimated GFR, ESR, CRP, urine analysis, ANA, anti dsDNA, C3 & C4, serum albumin, 24-hrs urinary protein, and U. ACRLaboratory tests including, complete blood count (CBC, serum creatinine and urea and estimated GFR according to CKD-EPI and KDIGO;2024, urine analysis, C-reactive protein (CRP), Erythrocyte Sedimination Rate (ESR), anti-nuclear antibodies (ANA), serum albumin, serum complement (C3 and C4) ,anti-double stranded deoxyribonucleic acid (anti-dsDNA), 24-hrs urinary protein and urinary albumin:creatinine ratio (U. ACR). | Diagnostic test | Healthy controls, LN group, SLE without nephritis |
Primary outcome
evaluate associations between anti-alpha-actinin antibody levels and specific histological features of active LN
Time frame: 36 months
To evaluate associations between anti-alpha-actinin antibody levels and specific histological features of active LN, including endocapillary hypercellularity, fibrinoid necrosis, and cellular crescents.
measure serum anti-alpha-actinin antibody levels in patients with biopsy-proven active lupus nephritis
Time frame: 36 months
To measure serum anti-alpha-actinin antibody levels in patients with biopsy-proven active lupus nephritis and assess their correlation with the NIH histopathological activity index.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 11884481Deocharan B, Qing X, Lichauco J, Putterman C. Alpha-actinin is a cross-reactive renal target for pathogenic anti-DNA antibodies. J Immunol. 2002 Mar 15;168(6):3072-8. doi: 10.4049/jimmunol.168.6.3072.
- Background: PubMed 37373215Tsai CY, Li KJ, Shen CY, Lu CH, Lee HT, Wu TH, Ng YY, Tsao YP, Hsieh SC, Yu CL. Decipher the Immunopathological Mechanisms and Set Up Potential Therapeutic Strategies for Patients with Lupus Nephritis. Int J Mol Sci. 2023 Jun 13;24(12):10066. doi: 10.3390/ijms241210066.
- Background: PubMed 41501150He S, Zhang J, Wang X, Qi Z, Zhou Z, Wang Y, Xu S, Li D, Ye X, Liu Z, Hao X, Zhao Y, Wang R. Organoid Modeling and Single-Cell Profiling Reveal Smooth Muscle Cell Migration in Moyamoya Disease. Commun Biol. 2026 Jan 7;9(1):198. doi: 10.1038/s42003-025-09476-9.
- Background: PubMed 31779843Aringer M. EULAR/ACR classification criteria for SLE. Semin Arthritis Rheum. 2019 Dec;49(3S):S14-S17. doi: 10.1016/j.semarthrit.2019.09.009.
- Background: PubMed 38255879Alduraibi FK, Tsokos GC. Lupus Nephritis Biomarkers: A Critical Review. Int J Mol Sci. 2024 Jan 9;25(2):805. doi: 10.3390/ijms25020805.
- Background: PubMed 11838846Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
- Background: PubMed 27821390Almaani S, Meara A, Rovin BH. Update on Lupus Nephritis. Clin J Am Soc Nephrol. 2017 May 8;12(5):825-835. doi: 10.2215/CJN.05780616. Epub 2016 Nov 7.
- Individual participant dataSharing planned: Undecided
Related trials for Lupus Nephritis
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis, 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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 1 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Essam Mohamed Abdel Aziz, MD (+201009699081, essam.abdelaziz@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate associations between anti-alpha-actinin antibody levels and specific histological features of active LN (time frame: 36 months). The study lists 2 primary outcomes in all. 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 NCT07505576, which also lists 7 linked publications.
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 1 Apr 2026.