GlomerulonephritisPhase 3NCT05283057
Empagliflozin in Patients With Glomerulonephritis
A Phase 3 study testing Empagliflozin 25 MG in people with Glomerulonephritis and Proteinuria, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Sodium-glucose cotransporter 2 (SGLT2) inhibitors are newly developed antihyperglycemic medications. In addition to their glucose lowering properties, they have been shown to have favourable effects on the cardiovascular and renal outcome in patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glomerulonephritis, Proteinuria
- What is being tested?
- Empagliflozin 25 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2020to 30 Sep 2021
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤75 years.
- Urinary protein excretion > 500 mg/g and eGFR ≥ 30 mL/min/1.73 m2 (CKD stages 1-3).
- On a stable dose of an ACEi or ARBs together with their immunosuppression protocol for at least 4 weeks prior to randomization.
- Who signed informed consent.
- Women of Child-Bearing Potential (WOCBP) used an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner that the risk of pregnancy was minimized.
Who cannot join
- a) Diagnosis of type 1 or type 2 diabetes mellitus b) Urinary protein excretion of less than 500 mg/g and eGFR < 30 ml/min
- 1.7m2 c) Active malignancy d) Any medication, surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: History of active inflammatory bowel disease within the last six months; Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months; Pancreatic injury or pancreatitis within the last six months.
- Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.
- Evidence of urinary tract obstruction. g) History of hypersensitivity or contraindications to empagliflozin. h) Subject who, in the assessment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data.
- Participation in any clinical investigation within 3 months prior to initial dosing.
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sodium Glucose Transporter 2 Inhibitor Empagliflozin on Proteinuria and Kidney Disease Progression in Patients With Non-diabetic Glomerulonephritis- A Randomized Controlled Trial
Sodium-glucose cotransporter 2 (SGLT2) inhibitors are newly developed antihyperglycemic medications. In addition to their glucose lowering properties, they have been shown to have favourable effects on the cardiovascular and renal outcome in patients with diabetes. one of the most interesting renal effects is reduction of proteinuria. The aim of our study was examine the effect of SGLT inhibitors on proteinuria in patients with glomerulonephritis. This study is a randomised controlled trial.
Read the detailed description
Sodium-glucose cotransporter 2 (SGLT2) inhibitors are newly developed antihyperglycemic medications. In addition to their glucose lowering properties, they have been shown to have favourable effects on the cardiovascular and renal outcome in patients with diabetes.The favourable cardiovascular effects include increased diuresis , reduction of blood pressure and reduction of hospitalisation for heart failure one of the most interesting renal effects is reduction of proteinuria. The aim of our study was examine the effect of SGLT inhibitors on proteinuria in patients with glomerulonephritis. This study is a randomised controlled trial.
- Conditions
- Glomerulonephritis, Proteinuria
- Being tested
- Empagliflozin 25 MG, placebo
- Keywords
- sodium glucose cotransporter inhibitors, Empagliflozin
- Medical subject headings
- Glomerulonephritis, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 25 MGDrug
Also called EMPA
single dose of the SGLT inhibitor Empagliflozin was given
placeboDrug
Also called PLAC
single dose of placebo that is similar to Empagliflozin in physical appearance
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Empagliflozin | Active comparator | 25 patients with glomerulonephritis and proteinuria who were treated with Empagliflozin Receives: Drug: Empagliflozin 25 MG |
| Group 2: | Placebo comparator | 25 patients with glomerulonephritis and proteinuria who were treated with standard treatment and placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
protein to creatinine ratio
measurement of urinary protein to creatinine ratio as a marker of proteinuria
Measured: 3 months
Secondary outcomes (1)
Decline of glomerular filtration rate
Decline in estimated glomerular filtration rate over
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start20 Feb 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlomerulonephritisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Samy Abdelaziz, Kasr El Aini Hospital
- Investigators
- Tarek Abdelaziz, PHD, Principal investigator, Kasr Alainy faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283057
- Sponsor's protocol ID
- KA-21-297
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Glucose Transporter 2 Inhibitor Empagliflozin on Proteinuria and Kidney Disease Progression in Patients With Non-diabetic Glomerulonephritis- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05283057
- Acronym / sponsor ID
- KA-21-297
- Conditions
- Glomerulonephritis, Proteinuria
- Keywords
- sodium glucose cotransporter inhibitors, Empagliflozin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 16 Mar 2022 (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.
Sodium-glucose cotransporter 2 (SGLT2) inhibitors are newly developed antihyperglycemic medications. In addition to their glucose lowering properties, they have been shown to have favourable effects on the cardiovascular and renal outcome in patients with diabetes. one of the most interesting renal effects is reduction of proteinuria. The aim of our study was examine the effect of SGLT inhibitors on proteinuria in patients with glomerulonephritis. This study is a randomised controlled trial.
Detailed description
Sodium-glucose cotransporter 2 (SGLT2) inhibitors are newly developed antihyperglycemic medications. In addition to their glucose lowering properties, they have been shown to have favourable effects on the cardiovascular and renal outcome in patients with diabetes.The favourable cardiovascular effects include increased diuresis , reduction of blood pressure and reduction of hospitalisation for heart failure one of the most interesting renal effects is reduction of proteinuria. The aim of our study was examine the effect of SGLT inhibitors on proteinuria in patients with glomerulonephritis. This study is a randomised controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Empagliflozin | Active comparator | Drug: Empagliflozin 25 MG25 patients with glomerulonephritis and proteinuria who were treated with Empagliflozin |
| Group 2: | Placebo comparator | Drug: placebo25 patients with glomerulonephritis and proteinuria who were treated with standard treatment and placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 and ≤75 years.
- Urinary protein excretion > 500 mg/g and eGFR ≥ 30 mL/min/1.73 m2 (CKD stages 1-3).
- On a stable dose of an ACEi or ARBs together with their immunosuppression protocol for at least 4 weeks prior to randomization.
- Who signed informed consent.
- Women of Child-Bearing Potential (WOCBP) used an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner that the risk of pregnancy was minimized.
Key exclusion criteria (7 listed)
- a) Diagnosis of type 1 or type 2 diabetes mellitus b) Urinary protein excretion of less than 500 mg/g and eGFR < 30 ml/min
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 |
|---|---|---|
| Empagliflozin 25 MGAlso: EMPAsingle dose of the SGLT inhibitor Empagliflozin was given | Drug | Group 1: Empagliflozin |
| placeboAlso: PLACsingle dose of placebo that is similar to Empagliflozin in physical appearance | Drug | Group 2: |
Primary outcome
protein to creatinine ratio
Time frame: 3 months
measurement of urinary protein to creatinine ratio as a marker of proteinuria
1 secondary outcome
Decline of glomerular filtration rate
Time frame: 3 months
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 16 Mar 2022.
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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.
Tarek Abdelaziz, PHD principal investigator
Kasr Alainy faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empagliflozin 25 MG in people with Glomerulonephritis and Proteinuria, run by Kasr El Aini Hospital 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 7 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 16 Mar 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
protein to creatinine ratio (time frame: 3 months). 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 16 Mar 2022.