Chronic Kidney DiseasesPhase 4NCT05735197
Effect of Dapagliflozin on Renal Outcomes and Bone Mineral Disease in Non-diabetic Chronic Kidney Disease Patients
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Chronic Kidney Diseases and Bone Diseases, Metabolic, run by Mansoura University at 1 site in Egypt.
Trial summary
It is a randomized controlled trial in which 100 non diabetic chronic kidney disease (CKD) patient is being participated. Their estimated glomerular filtration rate (eGFR) between 25-75 ml/min/1.73 m2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Bone Diseases, Metabolic
- What is being tested?
- Dapagliflozin 10mg Tab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Nov 2023
- 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
- Patients aged more than 18 year.
- CKD patient with eGFR from 25 to 75 ml/min/1.73m2 with no evidence of acute drop of the GFR in the last 3 months.
- Willing to sign informed consent.
Who cannot join
- eGFR less than 25 ml/min per 1.73 m2.
- Medical history of chronic disease (diabetes mellitus, chronic liver and/or respiratory diseases).
- Patients with primary or secondary glomerulonephritis/ nephrotic syndrome (proteinuria ≥ 3.5 gm/day) and/or any evidence of active immunological/ collagen vascular disease.
- Inability to sign the study consent form or refusal to participate in the study.
- Evidence of urinary obstruction.
- Patients with evidence of volume depletion or receiving a combination of angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBS)..
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- Patients with current history of frequent hypotensive episodes or systolic blood pressure <100 mmHg.
- Patients with history of recurrent urinary tract infection and/or valvovaginitis
- Patients with ongoing active malignancy.
- Patients with any evidence of active infection including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and tuberculosis (TB).
- Current or previous organ transplantation, or expected to get a kidney transplant within 12 months.
- Patients who received any SGLT2i for more than 3 months in the past.
- Patients who are already on medications that may affect or interact with bone metabolism such as bisphosphonates, calcitonin, steroid, denosumab and estrogen during the last 6 months.
- Pregnant and/or lactating woman.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and Nephrology center, Mansoura University
Al Mansurah, Aldakahliya, 35511
About this study
Official title: Effect of Sodium-Glucose Co-transporter 2 Inhibitors on Kidney Disease Progression and Bone Mineral Metabolism in Non-diabetic Patients With Chronic Kidney Disease
It is a randomized controlled trial in which 100 non diabetic chronic kidney disease (CKD) patient is being participated.
Their estimated glomerular filtration rate (eGFR) between 25-75 ml/min/1.73 m2.
Read more
Participants will be randomized into two groups:
- Study group: includes 50 patients, they will receive Sodium glucose co-transporter 2 inhibitor (SGLT2i) as add on drug, Dapagliflozin 10 mg will be used once daily with or without food.
- Control group: includes 50 patients, they will receive placebo their medication.
The investigators will follow up all patients for 12 months and compare their results.
This study aims to:
- Assess SGLT2i role in delaying the progression of ongoing chronic kidney disease.
- Study the impact of SGLT2i on bone and mineral metabolism in this patients' population.
Read the detailed description
All patients have been recruited from the renal clinic of Nephrology and transplantation unit. The entire study will be conducted at Urology and Nephrology center in Mansoura University.
Study design and sample size:
- Sample size: Was calculated based on previous research by (DAPA-CKD) study using G. power program with α error 0.05 and power 80% and it was equal to approximately 98 patients.
Type of the study: Randomized, controlled trial.
Patient's enrollment: 100 patients with non-diabetic CKD with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2 will be randomized into two groups:
- Study group: includes 50 patients, they will receive SGLT2i as add on drug, Dapagliflozin 10 mg will be used once daily with or without food.
- Control group: includes 50 patients, they will receive placebo plus their medication.
The investigators will follow up all patients for 12 months and compare their results.
Study Protocol:
- 100 patients will be included in the study. Patients will be randomized 1:1, either to a control group receiving placebo and an intervention group receiving 10 mg dapagliflozin daily.
The following data will be gathered and evaluated for all patients:
I- Baseline evaluation:
- Patients of both groups will be subjected to full history taking including duration and cause of CKD and drug history and routine clinical examination.
- Laboratory investigations:
- Serum creatinine, calcium, phosphorus and magnesium.
- 24 hour urine protein, Creatinine clearance, calcium and phosphorus
- Urine analysis with microscopy and random urine protein/creatinine ratio.
- Random blood sugar.
- Intact parathyroid hormone (iPTH).
- Urine pregnancy test for females in child bearing period.
- Bone turnover markers:
- Bone-specific alkaline phosphatase (BALP).
- Propeptides of type I procollagen (P1NP).
- Carboxy-terminal crosslinked telopeptide of type 1 collagen (CTX-1).
- Tartrate-resistant acid phosphatase (TRAP-5b).
- Radiological investigation:
Quantitative computed tomography: to detect cortical and trabecular bone density.
II-Evaluation throughout the study:
All patients will be evaluated every 3 months thereafter regarding:
- Thorough clinical evaluation including regular measurement of blood pressure and assessment of volume status each visit.
- Laboratory investigations:
- Serum creatinine, calcium, phosphorus and magnesium.
- 24 hour urine protein, Creatinine clearance, calcium and phosphorus
- Urine analysis with microscopy and random urine protein/creatinine ratio.
- Random blood sugar.
All patients will be evaluated at 12 month regarding:
- iPTH
- Bone turnover markers:
- Bone-specific alkaline phosphatase (BALP)
- Propeptides of type I procollagen (P1NP).
- Carboxy-terminal crosslinked telopeptide of type 1 collagen (CTX-1).
- Tartrate-resistant acid phosphatase (TRAP-5b).
- Quantitative computed tomography (QCT).
The main research question is: Does use of SGLT2i will slow down the progression of CKD in patients without diabetes? Will the use of SGLT2i have a negative impact on bone and mineral metabolism among these patients?
- Conditions
- Chronic Kidney Diseases, Bone Diseases, Metabolic
- Being tested
- Dapagliflozin 10mg Tab, Placebo
- Keywords
- CKD, Bone mineral disease, SGLT2i
- Medical subject headings
- Renal Insufficiency, Chronic, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Also called Dapagliflozin
Dapagliflozin which is (SGLT2 inhibitor) will be used as add on medication.
PlaceboDrug
Also called control
Placebo which has the same shape as Dapagliflozin but without active ingredient will be used as add on medication for control group.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin group | Active comparator | Includes 50 patients, they will receive SGLT2i as add on drug, Dapagliflozin 10 mg will be used once daily with or without food. Receives: Drug: Dapagliflozin 10mg Tab |
| Placebo group | Placebo comparator | Includes 50 patients, they will receive placebo plus their medication. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of dapagliflozin on CKD progression
effect of Dapagliflozin on eGFR (ml/min)
Measured: 1 year
Effect of dapagliflozin on Bone
effect on serum levels of bone turnover markers measured by ELISA
Measured: 1 year
Effect of dapagliflozin on minerals
effect of Dapagliflozin on calcium, phosphorus and magnesium
Measured: 1 year
Effect of dapagliflozin on BMD
assess Bone mineral disease (BMD) by using quantitative CT (QCT)
Measured: 1 year
Secondary outcomes (1)
Effect of dapagliflozin on blood pressure
follow up systolic and diastolic blood pressure throughout the study
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 posted21 Feb 2023
- Study start1 Sep 2022
- Primary completion10 Aug 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- 100 patients with non-diabetic CKD with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2 will be randomized into two groups: * Study group: includes 50 patients, they will receive SGLT2i as add on drug, Dapagliflozin 10 mg will be used once daily with or without food. * Control group: includes 50 patients, they will receive placebo plus their medication.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohsen Elshayeb, Mansoura University
- Investigators
- Mohamed Mohsen elshayeb, Msc, Principal investigator, Mansoura Urology and nephrology center, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735197
- Sponsor's protocol ID
- MD.22.02.600
- Status last verified
- Nov 2024
- First submitted
- 8 Feb 2023
- Last updated
- 8 Nov 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 publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium-Glucose Co-transporter 2 Inhibitors on Kidney Disease Progression and Bone Mineral Metabolism in Non-diabetic Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05735197
- Acronym / sponsor ID
- MD.22.02.600
- Conditions
- Chronic Kidney Diseases, Bone Diseases, Metabolic
- Keywords
- CKD, Bone mineral disease, SGLT2i
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 21 Feb 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.
It is a randomized controlled trial in which 100 non diabetic chronic kidney disease (CKD) patient is being participated.
Their estimated glomerular filtration rate (eGFR) between 25-75 ml/min/1.73 m2.
Participants will be randomized into two groups:
- Study group: includes 50 patients, they will receive Sodium glucose co-transporter 2 inhibitor (SGLT2i) as add on drug, Dapagliflozin 10 mg will be used once daily with or without food.
- Control group: includes 50 patients, they will receive placebo their medication.
The investigators will follow up all patients for 12 months and compare their results.
This study aims to:
- Assess SGLT2i role in delaying the progression of ongoing chronic kidney disease.
- Study the impact of SGLT2i on bone and mineral metabolism in this patients' population.
Detailed description
All patients have been recruited from the renal clinic of Nephrology and transplantation unit. The entire study will be conducted at Urology and Nephrology center in Mansoura University.
Study design and sample size:
- Sample size: Was calculated based on previous research by (DAPA-CKD) study using G. power program with α error 0.05 and power 80% and it was equal to approximately 98 patients.
Type of the study: Randomized, controlled trial.
Patient's enrollment: 100 patients with non-diabetic CKD with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2 will be randomized into two groups:
- Study group: includes 50 patients, they will receive SGLT2i as add on drug, Dapagliflozin 10 mg will be used once daily with or without food.
- Control group: includes 50 patients, they will receive placebo plus their medication.
The investigators will follow up all patients for 12 months and compare their results.
Study Protocol:
- 100 patients will be included in the study. Patients will be randomized 1:1, either to a control group receiving placebo and an intervention group receiving 10 mg dapagliflozin daily.
The following data will be gathered and evaluated for all patients:
I- Baseline evaluation:
- Patients of both groups will be subjected to full history taking including duration and cause of CKD and drug history and routine clinical examination.
- Laboratory investigations:
- Serum creatinine, calcium, phosphorus and magnesium.
- 24 hour urine protein, Creatinine clearance, calcium and phosphorus
- Urine analysis with microscopy and random urine protein/creatinine ratio.
- Random blood sugar.
- Intact parathyroid hormone (iPTH).
- Urine pregnancy test for females in child bearing period.
- Bone turnover markers:
- Bone-specific alkaline phosphatase (BALP).
- Propeptides of type I procollagen (P1NP).
- Carboxy-terminal crosslinked telopeptide of type 1 collagen (CTX-1).
- Tartrate-resistant acid phosphatase (TRAP-5b).
- Radiological investigation:
Quantitative computed tomography: to detect cortical and trabecular bone density.
II-Evaluation throughout the study:
All patients will be evaluated every 3 months thereafter regarding:
- Thorough clinical evaluation including regular measurement of blood pressure and assessment of volume status each visit.
- Laboratory investigations:
- Serum creatinine, calcium, phosphorus and magnesium.
- 24 hour urine protein, Creatinine clearance, calcium and phosphorus
- Urine analysis with microscopy and random urine protein/creatinine ratio.
- Random blood sugar.
All patients will be evaluated at 12 month regarding:
- iPTH
- Bone turnover markers:
- Bone-specific alkaline phosphatase (BALP)
- Propeptides of type I procollagen (P1NP).
- Carboxy-terminal crosslinked telopeptide of type 1 collagen (CTX-1).
- Tartrate-resistant acid phosphatase (TRAP-5b).
- Quantitative computed tomography (QCT).
The main research question is: Does use of SGLT2i will slow down the progression of CKD in patients without diabetes? Will the use of SGLT2i have a negative impact on bone and mineral metabolism among these patients?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 100 patients with non-diabetic CKD with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2 will be randomized into two groups: * Study group: includes 50 patients, they will receive SGLT2i as add on drug, Dapagliflozin 10 mg will be used once daily with or without food. * Control group: includes 50 patients, they will receive placebo plus their medication.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin group | Active comparator | Drug: Dapagliflozin 10mg TabIncludes 50 patients, they will receive SGLT2i as add on drug, Dapagliflozin 10 mg will be used once daily with or without food. |
| Placebo group | Placebo comparator | Drug: PlaceboIncludes 50 patients, they will receive placebo plus their medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged more than 18 year.
- CKD patient with eGFR from 25 to 75 ml/min/1.73m2 with no evidence of acute drop of the GFR in the last 3 months.
- Willing to sign informed consent.
Key exclusion criteria (14 listed)
- eGFR less than 25 ml/min per 1.73 m2.
- Medical history of chronic disease (diabetes mellitus, chronic liver and/or respiratory diseases).
- Patients with primary or secondary glomerulonephritis/ nephrotic syndrome (proteinuria ≥ 3.5 gm/day) and/or any evidence of active immunological/ collagen vascular disease.
- Inability to sign the study consent form or refusal to participate in the study.
- Evidence of urinary obstruction.
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 10mg TabAlso: DapagliflozinDapagliflozin which is (SGLT2 inhibitor) will be used as add on medication. | Drug | Dapagliflozin group |
| PlaceboAlso: controlPlacebo which has the same shape as Dapagliflozin but without active ingredient will be used as add on medication for control group. | Drug | Placebo group |
Primary outcome
Effect of dapagliflozin on CKD progression
Time frame: 1 year
effect of Dapagliflozin on eGFR (ml/min)
Effect of dapagliflozin on Bone
Time frame: 1 year
effect on serum levels of bone turnover markers measured by ELISA
Effect of dapagliflozin on minerals
Time frame: 1 year
effect of Dapagliflozin on calcium, phosphorus and magnesium
Effect of dapagliflozin on BMD
Time frame: 1 year
assess Bone mineral disease (BMD) by using quantitative CT (QCT)
1 secondary outcome
Effect of dapagliflozin on blood pressure
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 8 Nov 2024.
- Individual participant dataSharing planned: Yes. all individual participant data (IPD) that underlie results in 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.
Mohamed Mohsen elshayeb, Msc principal investigator
Mansoura Urology and nephrology center, Mansoura University
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 10mg Tab in people with Chronic Kidney Diseases and Bone Diseases, Metabolic, 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 3 inclusion and 14 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 8 Nov 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 CKD progression (time frame: 1 year). The study lists 4 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 8 Nov 2024.