Activity of Lupus NepheritisNCT04468438
Role of Estrogen in the Flarring up of Lupus Nepheritis
An observational study of Activity of Lupus Nepheritis, run by Assiut University.
Trial summary
Role of estrogen in the flarring up of lupus nepheritis Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Activity of Lupus Nepheritis
- What is being tested?
- serum estrogen and urinary albumin creatinine ratio
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 1 Mar 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: female patients at the reproductive age with systemic lupus divided into two groups: 1. First group patients with regular menstrual cycle. 2. Second group patients with amenorrhea.
Who may be able to join
- Patients with SLE complicated with LN.
- Patients with age more than 18 years old.
Who cannot join
- 1- Pragnancy, lactation. 2- Menpause. 3- Primary amenorrhea. 4- Patients with current use of oral contraceptive agents. 5- Patients who receive pulse therapy during the study
Trial locations and contacts
No sites are listed yet.
About this study
Role of estrogen in the flarring up of lupus nepheritis
Read the detailed description
Systemic lupus erythematosus SLE is an autoimmune disease that affects ∼5.5 per 100,000 individuals worldwide . SLE is characterized by loss of tolerance against nuclear autoantigens, lymphoproliferation, polyclonal autoantibody production, immune complex disease, and multiorgan tissue inflammation. Up to 50% of SLE patients develop some degree of renal involvement, with up to 20% progressing to end-stage renal disease, depending on racial background . Lupus nephritis LN is characterized by anti-nuclear Ab production, immune complex deposition, and immune-mediated kidney damage. Development of LN remains a sign of poor prognosis and is a significant cause of morbidity and mortality . Because 9 of 10 SLE patients are women, the role of the sex hormones estrogens in this disease is of key interest. Estrogens signal through two receptors: estrogen receptor a ERa and estrogen receptor b ERb. In contrast to estrogen receptor b, ERa is found in female reproductive organs, yet is robustly expressed in kidney, liver, heart, and lungs in males and females,as well as on most immune cells however the kidney is considered the most estrogenic nonreproductive organ. The overwhelming female predominance for SLE begins at puberty and extends to menopause , supporting the concept that estrogens or other reproductive factors stimulate lupus development. This concept is further evidenced by reports of menstrual cycle flares of SLE , disease exacerbations by oral contraceptives or estrogen administration , and induction of lupus by ovulation regimens . Ultraviolet rays has arole in the flarring up SLE. There is evidence that fibroblasts and blood lymphocytes from SLE patients are hypersensitive to the cytotoxic effects of UV light radiation
. RNA and protein synthesis is also affected by UV light 18. A study from 1986 found that people were more likely to menstruate during a new moon, which occurs during the opposite half of the lunar cycle than the full moon . There are different evolutionary theories speculating why the human menstrual cycle length evolved to be so close to the lunar cycle in length. Stories and beliefs connecting the two are also found in various cultures and mythologies . The terms menstruation and menses even come from Latin and Greek words meaning month mensis and moon mene
- Conditions
- Activity of Lupus Nepheritis
- Being tested
- serum estrogen and urinary albumin creatinine ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum estrogen and urinary albumin creatinine ratioDiagnostic test
serum estrogen and urinary albumin creatinine ratio
| Study group | Role | What they receive |
|---|---|---|
| 50 patients with LN with regular menstrual cycle | 1- First group of50 patients with regular menstrual cycle Receives: Diagnostic Test: serum estrogen and urinary albumin creatinine ratio | |
| 50 patients with LN with amenorrhea | 2- Second group of 50 patients with amenorrhea. Receives: Diagnostic Test: serum estrogen and urinary albumin creatinine ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role af estrogen in flarring up of lupus nepheritis to detect time of pulse therapy
Measurement of estrogen in the first day of menstruation and the14th day of menstruation To intensify treatment during days of menstruation or days of full moon.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Activity of Lupus NepheritisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Zanaty Abdelraouf, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468438
- Sponsor's protocol ID
- Example 3
- Status last verified
- Nov 2019
- First submitted
- 29 Jan 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Somers EC, Marder W, Cagnoli P, Lewis EE, DeGuire P, Gordon C, Helmick CG, Wang L, Wing JJ, Dhar JP, Leisen J, Shaltis D, McCune WJ. Population-based incidence and prevalence of systemic lupus erythematosus: the Michigan Lupus Epidemiology and Surveillance program. Arthritis Rheumatol. 2014 Feb;66(2):369-78. doi: 10.1002/art.38238.
PubMed 24504809Tan DA, Haththotuwa R, Fraser IS. Cultural aspects and mythologies surrounding menstruation and abnormal uterine bleeding. Best Pract Res Clin Obstet Gynaecol. 2017 Apr;40:121-133. doi: 10.1016/j.bpobgyn.2016.09.015. Epub 2016 Oct 26.
PubMed 27863914Liu Z, Davidson A. Taming lupus-a new understanding of pathogenesis is leading to clinical advances. Nat Med. 2012 Jun 6;18(6):871-82. doi: 10.1038/nm.2752.
PubMed 22674006Moulton VR, Tsokos GC. Abnormalities of T cell signaling in systemic lupus erythematosus. Arthritis Res Ther. 2011 Mar 17;13(2):207. doi: 10.1186/ar3251.
PubMed 21457530
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Estrogen in the Flarring up of Lupus Nepheritis
- ClinicalTrials.gov ID
- NCT04468438
- Acronym / sponsor ID
- Example 3
- Conditions
- Activity of Lupus Nepheritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 13 Jul 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.
Role of estrogen in the flarring up of lupus nepheritis
Detailed description
Systemic lupus erythematosus SLE is an autoimmune disease that affects ∼5.5 per 100,000 individuals worldwide . SLE is characterized by loss of tolerance against nuclear autoantigens, lymphoproliferation, polyclonal autoantibody production, immune complex disease, and multiorgan tissue inflammation. Up to 50% of SLE patients develop some degree of renal involvement, with up to 20% progressing to end-stage renal disease, depending on racial background . Lupus nephritis LN is characterized by anti-nuclear Ab production, immune complex deposition, and immune-mediated kidney damage. Development of LN remains a sign of poor prognosis and is a significant cause of morbidity and mortality . Because 9 of 10 SLE patients are women, the role of the sex hormones estrogens in this disease is of key interest. Estrogens signal through two receptors: estrogen receptor a ERa and estrogen receptor b ERb. In contrast to estrogen receptor b, ERa is found in female reproductive organs, yet is robustly expressed in kidney, liver, heart, and lungs in males and females,as well as on most immune cells however the kidney is considered the most estrogenic nonreproductive organ. The overwhelming female predominance for SLE begins at puberty and extends to menopause , supporting the concept that estrogens or other reproductive factors stimulate lupus development. This concept is further evidenced by reports of menstrual cycle flares of SLE , disease exacerbations by oral contraceptives or estrogen administration , and induction of lupus by ovulation regimens . Ultraviolet rays has arole in the flarring up SLE. There is evidence that fibroblasts and blood lymphocytes from SLE patients are hypersensitive to the cytotoxic effects of UV light radiation
. RNA and protein synthesis is also affected by UV light 18. A study from 1986 found that people were more likely to menstruate during a new moon, which occurs during the opposite half of the lunar cycle than the full moon . There are different evolutionary theories speculating why the human menstrual cycle length evolved to be so close to the lunar cycle in length. Stories and beliefs connecting the two are also found in various cultures and mythologies . The terms menstruation and menses even come from Latin and Greek words meaning month mensis and moon mene
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 patients with LN with regular menstrual cycle | – | Diagnostic Test: serum estrogen and urinary albumin creatinine ratio1- First group of50 patients with regular menstrual cycle |
| 50 patients with LN with amenorrhea | – | Diagnostic Test: serum estrogen and urinary albumin creatinine ratio2- Second group of 50 patients with amenorrhea. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- female patients at the reproductive age with systemic lupus divided into two groups: 1. First group patients with regular menstrual cycle. 2. Second group patients with amenorrhea.
Key inclusion criteria (2 listed)
- Patients with SLE complicated with LN.
- Patients with age more than 18 years old.
Key exclusion criteria (1 listed)
- 1- Pragnancy, lactation. 2- Menpause. 3- Primary amenorrhea. 4- Patients with current use of oral contraceptive agents. 5- Patients who receive pulse therapy during the study
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 estrogen and urinary albumin creatinine ratioserum estrogen and urinary albumin creatinine ratio | Diagnostic test | 50 patients with LN with amenorrhea, 50 patients with LN with regular menstrual cycle |
Primary outcome
Role af estrogen in flarring up of lupus nepheritis to detect time of pulse therapy
Time frame: one year
Measurement of estrogen in the first day of menstruation and the14th day of menstruation To intensify treatment during days of menstruation or days of full moon.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Background: PubMed 24504809Somers EC, Marder W, Cagnoli P, Lewis EE, DeGuire P, Gordon C, Helmick CG, Wang L, Wing JJ, Dhar JP, Leisen J, Shaltis D, McCune WJ. Population-based incidence and prevalence of systemic lupus erythematosus: the Michigan Lupus Epidemiology and Surveillance program. Arthritis Rheumatol. 2014 Feb;66(2):369-78. doi: 10.1002/art.38238.
- Background: PubMed 27863914Tan DA, Haththotuwa R, Fraser IS. Cultural aspects and mythologies surrounding menstruation and abnormal uterine bleeding. Best Pract Res Clin Obstet Gynaecol. 2017 Apr;40:121-133. doi: 10.1016/j.bpobgyn.2016.09.015. Epub 2016 Oct 26.
- Background: PubMed 22674006Liu Z, Davidson A. Taming lupus-a new understanding of pathogenesis is leading to clinical advances. Nat Med. 2012 Jun 6;18(6):871-82. doi: 10.1038/nm.2752.
- Background: PubMed 21457530Moulton VR, Tsokos GC. Abnormalities of T cell signaling in systemic lupus erythematosus. Arthritis Res Ther. 2011 Mar 17;13(2):207. doi: 10.1186/ar3251.
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 Activity of Lupus Nepheritis, 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 2 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 13 Jul 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 hager zanaty, resident doctor (01091250220, hagerzanatyabd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role af estrogen in flarring up of lupus nepheritis to detect time of pulse therapy (time frame: one year). 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 NCT04468438, which also lists 4 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 13 Jul 2020.