SGLT2 INHIBITORSPhase 4NCT05704088
SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Lupus Nephritis Patients
A Phase 4 study testing Dapagliflozin tablet in people with SGLT2 INHIBITORS and Lupus Nephritis, run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of this Randomized, controlled trial in 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center. 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SGLT2 INHIBITORS, Lupus Nephritis, BMD
- What is being tested?
- Dapagliflozin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Oct 2022to 8 Jan 2024
- Phase
- Phase 4
- 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 of patient is more than 18.
- Patients who are willing to sign informed consent.
- Patients with SLE diagnosed according to EULAR/ACR classification criteria.
- Patients with LN according to renal biopsy.
- Patients with eGFR > 30 ml/min/1.73m2.
Who cannot join
- With eGFR <30 ml/min per 1.73 m2.
- Who is currently pregnancy or lactation.
- With medical history of chronic disease (chronic liver disease, cancer, severe respiratory distress, gastrointestinal tract lesions).
- Refuse to participate in the study or lost follow up.
- With evidence of urinary obstruction of difficulty in voiding at screening.
- Who are receiving high dose diuretics or combined angiotensin-converting enzyme inhibitor (ACEI) and Angiotensin II receptor blockers (ARBS).
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- Who have frequent hypotensive episode or systolic blood pressure <100 mmHg. Active malignancy.
- Active infection including HIV.
- Any medications that may affect or interact with bone metabolism such as calcitonin, , denosumab, estrogen and fluoride during the last 6 months.
- Current or previous organ transplantation, or expected to get a kidney transplant within 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Diabetic and Non- Diabetic Lupus Nephritis Patients
The goal of this Randomized, controlled trial in 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.
- The main questions it aims to answer are:
Read more
- Assess the role of sodium glucose co transporter 2 inhibitors (SGLT2i) in regression of ongoing kidney and cardiac diseases among diabetic or non-diabetic patients with lupus nephritis (LN) under different immunosuppressive therapies.
- Investigate the impact of SGLT2i on bone and mineral metabolism in these patients.
Participants will be randomized into two groups :
- Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
- Control group: will be maintained on their medication.
Read the detailed description
Study sitting: Nephrology and renal transplant unit at urology and nephrology center in Mansoura University.
Study design and sample size:
Randomized, controlled trial that will include 100 patients with Lupus nephritis (LN) with an estimated glomerular filtration rate of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.
The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
Control group: will be maintained on their medication.
Study Protocol:
Patients in the study group will treated with dapagliflozin initiated at a total daily dosage of 10 mg once daily.
Methods:
The following data will be gathered and evaluated for all patients:
I-before intervention:
Patients of both groups will be subjected to full history taking including duration of LN and drug history and routine clinical examination including blood pressure and BMI measurements.
Laboratory investigations:
Serum creatinine, Creatinine clearance. 24 hour urine protein, urine protein/creatinine ratio. Urine analysis. HBA1c. hemoglobin (HGB). Uric acid and lipid profile. Lupus serology. immunoreactive parathyroid hormone (iPTH). Vitamin D level. Fibroblast growth factor 23 level. bone turnover markers : bone specific alkaline phosphates propeptides of type 1 procollagen tartrate resistant acid phosphatase 5b sclerostin level
Radiological investigation:
Quantitative computed tomography: to detect bone and mineral density (BMD). Cardiovascular assessment: Echocardiography and vascular calcification incidence (NCCT model) : for detection of coronary calcification.
II-after intervention:
All patients will be evaluated monthly regarding:
Regular measurement of blood pressure each visit.
Laboratory investigations:
Serum creatinine, creatinine clearance. 24 hour proteinuria, protein/creatinine ratio. Fasting, random and postprandial glucose levels. calcineurin inhibitors (CNI) trough level if used. Urine analysis. HGB level. Uric acid, lipid profile. Lupus serology.
All patients will be evaluated every 3 month regarding:
- iPTH
- Vitamin D level
All patients will be evaluated at 12 month regarding:
- Fibroblast growth factor 23 level
- High resolution quantitative computed tomography.
- Bone turnover markers.
- Conditions
- SGLT2 INHIBITORS, Lupus Nephritis, BMD
- Being tested
- Dapagliflozin tablet, placebo
- Keywords
- SGLT2 INHIBITORS, BMD, systemic lupus erythematosus
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin tabletDrug
randomized control trial, study group will receive dapagliflozin tablets
placeboDrug
randomized control trial, control group will receive placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one year. Receives: Drug: Dapagliflozin tablet |
| control group | Placebo comparator | Control group: will receive placebo as add on drug once daily with or without food for one year. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of dapagliflozin on renal function
Effect of dapagliflozin on eGFR (ml/ min).
Measured: 1 year
effect of dapagliflozin on kidney function
Effect of dapagliflozin on s.creatinine (mg/dl).
Measured: 1 year
effect of dapagliflozin on BMD
Effect of dapagliflozin on osteoporosis using Qct
Measured: 1 year
effect of dapagliflozin on minerals
Effect of dapagliflozin on serum calcium and phosphorus (mg/dl)
Measured: 1 year
effect of dapagliflozin on Bone
Effect of dapagliflozin on bone turnover markers (ng/dl)
Measured: 1 year
Secondary outcomes (2)
effect of dapagliflozin on blood pressure
measuring systolic and diastolic blood pressure mmgh before and after intervention
Measured: 1 year
effect of dapagliflozin on body weight
assessing body weight in kg before and after intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start8 Oct 2022
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SGLT2 INHIBITORSStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled trial that will include 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center. The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food. Control group: will be maintained on their medication.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hosny, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704088
- Sponsor's protocol ID
- MD.21.12.574
- Status last verified
- Oct 2024
- First submitted
- 10 Jan 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data (IPD) that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Diabetic and Non- Diabetic Lupus Nephritis Patients
- ClinicalTrials.gov ID
- NCT05704088
- Acronym / sponsor ID
- MD.21.12.574
- Conditions
- SGLT2 INHIBITORS, Lupus Nephritis, BMD
- Keywords
- SGLT2 INHIBITORS, BMD, systemic lupus erythematosus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 30 Jan 2023 (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 goal of this Randomized, controlled trial in 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.
- The main questions it aims to answer are:
- Assess the role of sodium glucose co transporter 2 inhibitors (SGLT2i) in regression of ongoing kidney and cardiac diseases among diabetic or non-diabetic patients with lupus nephritis (LN) under different immunosuppressive therapies.
- Investigate the impact of SGLT2i on bone and mineral metabolism in these patients.
Participants will be randomized into two groups :
- Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
- Control group: will be maintained on their medication.
Detailed description
Study sitting: Nephrology and renal transplant unit at urology and nephrology center in Mansoura University.
Study design and sample size:
Randomized, controlled trial that will include 100 patients with Lupus nephritis (LN) with an estimated glomerular filtration rate of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.
The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
Control group: will be maintained on their medication.
Study Protocol:
Patients in the study group will treated with dapagliflozin initiated at a total daily dosage of 10 mg once daily.
Methods:
The following data will be gathered and evaluated for all patients:
I-before intervention:
Patients of both groups will be subjected to full history taking including duration of LN and drug history and routine clinical examination including blood pressure and BMI measurements.
Laboratory investigations:
Serum creatinine, Creatinine clearance. 24 hour urine protein, urine protein/creatinine ratio. Urine analysis. HBA1c. hemoglobin (HGB). Uric acid and lipid profile. Lupus serology. immunoreactive parathyroid hormone (iPTH). Vitamin D level. Fibroblast growth factor 23 level. bone turnover markers : bone specific alkaline phosphates propeptides of type 1 procollagen tartrate resistant acid phosphatase 5b sclerostin level
Radiological investigation:
Quantitative computed tomography: to detect bone and mineral density (BMD). Cardiovascular assessment: Echocardiography and vascular calcification incidence (NCCT model) : for detection of coronary calcification.
II-after intervention:
All patients will be evaluated monthly regarding:
Regular measurement of blood pressure each visit.
Laboratory investigations:
Serum creatinine, creatinine clearance. 24 hour proteinuria, protein/creatinine ratio. Fasting, random and postprandial glucose levels. calcineurin inhibitors (CNI) trough level if used. Urine analysis. HGB level. Uric acid, lipid profile. Lupus serology.
All patients will be evaluated every 3 month regarding:
- iPTH
- Vitamin D level
All patients will be evaluated at 12 month regarding:
- Fibroblast growth factor 23 level
- High resolution quantitative computed tomography.
- Bone turnover markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, controlled trial that will include 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center. The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food. Control group: will be maintained on their medication.
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Drug: Dapagliflozin tabletStudy group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one year. |
| control group | Placebo comparator | Drug: placeboControl group: will receive placebo as add on drug once daily with or without food for one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of patient is more than 18.
- Patients who are willing to sign informed consent.
- Patients with SLE diagnosed according to EULAR/ACR classification criteria.
- Patients with LN according to renal biopsy.
- Patients with eGFR > 30 ml/min/1.73m2.
Key exclusion criteria (10 listed)
- With eGFR <30 ml/min per 1.73 m2.
- Who is currently pregnancy or lactation.
- With medical history of chronic disease (chronic liver disease, cancer, severe respiratory distress, gastrointestinal tract lesions).
- Refuse to participate in the study or lost follow up.
- With evidence of urinary obstruction of difficulty in voiding at screening.
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 |
|---|---|---|
| Dapagliflozin tabletrandomized control trial, study group will receive dapagliflozin tablets | Drug | study group |
| placeborandomized control trial, control group will receive placebo tablets | Drug | control group |
Primary outcome
effect of dapagliflozin on renal function
Time frame: 1 year
Effect of dapagliflozin on eGFR (ml/ min).
effect of dapagliflozin on kidney function
Time frame: 1 year
Effect of dapagliflozin on s.creatinine (mg/dl).
effect of dapagliflozin on BMD
Time frame: 1 year
Effect of dapagliflozin on osteoporosis using Qct
effect of dapagliflozin on minerals
Time frame: 1 year
Effect of dapagliflozin on serum calcium and phosphorus (mg/dl)
effect of dapagliflozin on Bone
Time frame: 1 year
Effect of dapagliflozin on bone turnover markers (ng/dl)
2 secondary outcomes
effect of dapagliflozin on blood pressure
Time frame: 1 year
effect of dapagliflozin on body weight
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. all individual participant data (IPD) that underlie results in a publication
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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.
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 Phase 4 study testing Dapagliflozin tablet in people with SGLT2 INHIBITORS and Lupus Nephritis, run by Mansoura University at 1 site in Egypt.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 15 Oct 2024. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
effect of dapagliflozin on renal function (time frame: 1 year). The study lists 5 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 15 Oct 2024.