Diabetic Nephropathy Type 2Phase 3NCT05487755
Investigational and Comparative Study in the Management of Diabetic Nephropathy
A Phase 3 study testing Tadalafil 20Mg Oral Tablet and Pentoxifylline 400 MG Oral Tablet in people with Diabetic Nephropathy Type 2, run by Tanta University at 1 site in Egypt.
Trial summary
The objective of this study is to investigate and compare the safety and efficacy of selective (PDE5) enzyme inhibitor; tadalafil and non selective (PDE) inhibitor; pentoxifylline in diabetic nephropathy to improve glucose metabolism, lipid profile and decrease albuminuria. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetic Nephropathy Type 2
- What is being tested?
- Tadalafil 20Mg Oral Tablet and Pentoxifylline 400 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 1 Sep 2023
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed with clinical diagnosis of T2DM with duration at least 7 years to ensure established of micro-vascular complication (DKD).
- females (post-menopause), males with sufficient erectile function.
- Patients on stage 3 DN with evidence of persistent micro-albuminuria. All Abnormal tests of (UACR) must be confirmed in two out of three samples collected over a 6 month period before enrolled in the study.
- (urinary ACR≥30-300mg/g) in 3 consecutive measurements in 6 months period despite treatment with RAAS blockade(ramipril 10 mg ) ACEI or for at least 6 months period before enrollment in the study at maximum recommended tolerated dose.
- Exclusion Criteria:Cardiovascular disease: angina, arrhythmias, myocardial Infarction, heart failure (NYHA II -IV), uncontrolled hypertension > (170 \100 mm Hg) severe hypotension < (90\50 mm Hg), Hearing problem, vision defect, previous episodes of retinal / cerebral hemorrhage, psychiatric disease, thyroid disorders, alcohol abuse, smoking, Hepatic insufficiency (child -Pugh class C), (ALT or AST>3N), cholestasis, history of chronic inflammatory, immunologic or malignant disease. Acute inflammation or infectious disease in the previous 3 months, taking immunosuppressive treatment, Known allergy to tadalafil or methylxanthine, Use alpha one blockers, use of anti-oxidant drugs three months before enrollment in the study ,medications strongly alter CYP3A4 inducer or inhibitor, use of nitrates, other PDEI drugs, - Renal disease (acute kidney injury, recent exposure to radio- contrast media, creatinine clearance <30 ml/ min /1.73 m2 , bleeding disorders, peptic ulcer, and stroke, Pregnancy, lactation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigational and Comparative Study to Assess Safety and Effectiveness of Tadalafil and Pentoxifyllin in the Management of Diabetic Nephropathy
The objective of this study is to investigate and compare the safety and efficacy of selective (PDE5) enzyme inhibitor; tadalafil and non selective (PDE) inhibitor; pentoxifylline in diabetic nephropathy to improve glucose metabolism, lipid profile and decrease albuminuria.
Read the detailed description
Diabetic nephropathy(DN) is one of the major micro- vascular complications of diabetes mellitus and the leading cause of end-stage renal disease (ESRD) that require renal replacement therapies.
The average incidence of diabetic nephropathy is 3% per year during the first 10 to 20 years after diabetes onset. Diabetic nephropathy occurs in 20-40% of all diabetic patients.
Pathogenesis of diabetic nephropathy is complex and multi-factorial in which diabetes mellitus has more than pathway for initiation and progression of the disease.
- Metabolic pathway: result in formation of advanced glycation end products (AGEs).
- Inflammatory pathway: result in increase serum level of tumor necrosis factor-α(TNF .
- Hemodynamic pathway: result in increase serum level of endothelin-1 which result in glomerular hypertension and hyper filtration.
Tadalafil is a phosphodiesterase type 5 enzyme (PDE5) inhibitor used mainly in erectile dysfunction and pulmonary hypertension by a mechanism involving increase(NO-cGMP-PKG) signaling pathway.
Tadalafil is a powerful pleiotropic drug that it can be used in DN as it can target more than pathway involved in pathogenesis of DN include hyperglycemia and endothelial dysfunction through increase (NO-cGMP) signaling pathway as well as hyperlipidemia. Animal studies reported that tadalafil increase significantly total antioxidant capacity(TAC),decrease significantly serum level of inflammatory marker (TNF- α), blood glucose level, serum creatinine ,serum urea and urinary albumin excretion all result in decrease renal inflammation, injury, necrosis and apoptosis.
Pentoxifylline is a methyl xanthine derivative, non selective phosphodiesterase enzyme inhibitor used mainly to treat peripheral vascular diseases by improve blood flow, increase red blood cell flexibility and inhibit platelet aggregation.
Pentoxifylline have been recently widely used in many animal studies and clinical trials to evaluate its efficacy in management of DN and the results were so promising.(14)
Pentoxifylline can slow the decrease in eGFR, and significantly reduce albuminuria in which it can be effective alternative to ACEI in reducing albuminuria as proved by clinical trial.(15) The powerful effect of pentoxifylline in DN as it can affect several pathways implicated in pathogenesis of DN; it has hypoglycemic effect by decrease Significantly blood glucose, HbA1c and serum triglyceride, it also decrease pro inflammatory cytokines (TNF-α, IL-1, IL-6), reduce plasma level of malondialdehyde and increase glutathione level.(16)
Neutrophil Gelatinase-Associated Lipocalin (NGAL): is a 25-kDa protein belong to lipocalin superfamily. The urinary concentration of NGAL increase in renal tubular damage as a result of both diminished reabsorption and increased release from renal tubules into urine indicating both proximal and distal tubular damage respectively.(17) NGAL is not considered a marker of renal function but a marker of structural damage of renal tubules, its level can quantify the degree of tubular damage.(18) NGAL can be used as a precocious marker of therapeutic response by application of NGAL measurement in monitoring the effectiveness of a particular treatment and predicting different clinical outcomes in the course of renal diseases
- Conditions
- Diabetic Nephropathy Type 2
- Being tested
- Tadalafil 20Mg Oral Tablet, Pentoxifylline 400 MG Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 20Mg Oral TabletDrug
Also called cialong
Tadalafil is a phosphodiesterase type 5 enzyme (PDE5) inhibitor used mainly in erectile dysfunction and pulmonary hypertension by a mechanism involving increase(NO-cGMP-PKG) signaling pathway.(8) Tadalafil is a powerful pleiotropic drug that it can be used in DN as it can target more than pathway involved in pathogenesis of DN include hyperglycemia and endothelial dysfunction through increase (NO-cGMP) signaling pathway as well as hyperlipidemia
Pentoxifylline 400 MG Oral TabletDrug
Also called Pental SR
Pentoxifylline is a methyl xanthine derivative, non selective phosphodiesterase enzyme inhibitor used mainly to treat peripheral vascular diseases by improve blood flow
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | : (n=30) control group will receive traditional therapy blood glucose lowering agent +RAAS blockade ACEI or ARBs for six months. |
| Tadalafil group | Experimental | :( n=30) will receive traditional therapy +tadalafil PO 20 mg every other day for six months Receives: Drug: Tadalafil 20Mg Oral Tablet |
| pentoxifylline group | Experimental | :( n=30) will receive traditional therapy+ pentoxifylline PO 400 mg twice daily for six months. Receives: Drug: Pentoxifylline 400 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary albumin/creatinine ratio (ACR)
Measurement of urine albumin to creatinne ratio by measurement of urine albumin using Turbidimetric immunoassay method and measurement of urine creatinnie by standard by enzymatic colorimetric methods
Measured: Change between baseline and six months after
Change in Hemoglobin A1c (HbA1c).
Measurement of Hemoglobin A1C using (HPLC: ion exchange chromatography)
Measured: Change between baseline and six months after
Change in Fasting blood glucose.
Measurement of Fasting blood glucose by using standard enzymatic colorimetric methods
Measured: Change between baseline and six months after
Change in Sr Cr
Measurement of serum creatinine using colorimetric technique
Measured: Change between baseline and six months after
Change in Creatinine clearance
Creatinine clearance was calculated by (Cockcroft-Gault Formula)
Measured: Change between baseline and six months after
change in 2- Hours Postprandial blood glucose
Measurement 2- Hours Postprandial blood glucose in blood using standard enzymatic colorimetric methods
Measured: Change between baseline and six months after
Secondary outcomes (4)
Change in serum ((TNF-α).
Measurement of serum level of (TNF-α) by Enzyme linked immunosorbent assay (ELISA).
Measured: Change between baseline and six months after
Change in Urinary NGAL (uNGAL).
Measurement of urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL)using by Enzyme linked immunosorbent assay ELISA technique:
Measured: Change between baseline and six months after
Change in Lipid profile (TG, LDL, and HDL).
Measurement of serum lipid profile (TC,TG,HDL,LDL)using Enzymatic Colorimetric Method
Measured: Change between baseline and six months after
Change in serum malondialdehyde (MDA) .
Meaurement of serum malondialdehyde by Enzyme linked immunosorbent assay (ELISA) .
Measured: Change between baseline and six months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Feb 2022
- Primary completion1 Mar 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic Nephropathy Type 2Studies of the same condition, open and under way.
- More trials run by Tanta 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * This is a randomized, controlled, prospective study. * Ninety diabetic nephropathy patients at stage 3(micro-albuminuria) will be divided into three groups as follow -Group 1: (n=30) control group will receive traditional therapy blood glucose lowering agent +RAAS blockade ACEI or ARBs for six months. * Group 2 :( n=30) will receive traditional therapy +tadalafil PO 20 mg every other day for six months. Group 3 :( n=30) will receive traditional therapy+ pentoxifylline PO 400 mg twice daily for six months.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walla Ahmed Amaar, Tanta University
- Investigators
- Wafaa S Hegab, Lecturer, Study chair, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487755
- Sponsor's protocol ID
- DN mangement
- Status last verified
- May 2024
- First submitted
- 22 Jul 2022
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rivero A, Mora C, Muros M, Garcia J, Herrera H, Navarro-Gonzalez JF. Pathogenic perspectives for the role of inflammation in diabetic nephropathy. Clin Sci (Lond). 2009 Mar;116(6):479-92. doi: 10.1042/CS20080394.
PubMed 19200057Wada J, Makino H. Inflammation and the pathogenesis of diabetic nephropathy. Clin Sci (Lond). 2013 Feb;124(3):139-52. doi: 10.1042/CS20120198.
PubMed 23075333Hegazy SK, Amaar WA, Hegab WSM. Tadalafil versus pentoxifylline in the management of diabetic kidney disease: a randomized clinical trial. Diabetol Metab Syndr. 2024 Jun 24;16(1):138. doi: 10.1186/s13098-024-01363-3.
PubMed 38915115
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational and Comparative Study to Assess Safety and Effectiveness of Tadalafil and Pentoxifyllin in the Management of Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT05487755
- Acronym / sponsor ID
- DN mangement
- Conditions
- Diabetic Nephropathy Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 4 Aug 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.
The objective of this study is to investigate and compare the safety and efficacy of selective (PDE5) enzyme inhibitor; tadalafil and non selective (PDE) inhibitor; pentoxifylline in diabetic nephropathy to improve glucose metabolism, lipid profile and decrease albuminuria.
Detailed description
Diabetic nephropathy(DN) is one of the major micro- vascular complications of diabetes mellitus and the leading cause of end-stage renal disease (ESRD) that require renal replacement therapies.
The average incidence of diabetic nephropathy is 3% per year during the first 10 to 20 years after diabetes onset. Diabetic nephropathy occurs in 20-40% of all diabetic patients.
Pathogenesis of diabetic nephropathy is complex and multi-factorial in which diabetes mellitus has more than pathway for initiation and progression of the disease.
- Metabolic pathway: result in formation of advanced glycation end products (AGEs).
- Inflammatory pathway: result in increase serum level of tumor necrosis factor-α(TNF .
- Hemodynamic pathway: result in increase serum level of endothelin-1 which result in glomerular hypertension and hyper filtration.
Tadalafil is a phosphodiesterase type 5 enzyme (PDE5) inhibitor used mainly in erectile dysfunction and pulmonary hypertension by a mechanism involving increase(NO-cGMP-PKG) signaling pathway.
Tadalafil is a powerful pleiotropic drug that it can be used in DN as it can target more than pathway involved in pathogenesis of DN include hyperglycemia and endothelial dysfunction through increase (NO-cGMP) signaling pathway as well as hyperlipidemia. Animal studies reported that tadalafil increase significantly total antioxidant capacity(TAC),decrease significantly serum level of inflammatory marker (TNF- α), blood glucose level, serum creatinine ,serum urea and urinary albumin excretion all result in decrease renal inflammation, injury, necrosis and apoptosis.
Pentoxifylline is a methyl xanthine derivative, non selective phosphodiesterase enzyme inhibitor used mainly to treat peripheral vascular diseases by improve blood flow, increase red blood cell flexibility and inhibit platelet aggregation.
Pentoxifylline have been recently widely used in many animal studies and clinical trials to evaluate its efficacy in management of DN and the results were so promising.(14)
Pentoxifylline can slow the decrease in eGFR, and significantly reduce albuminuria in which it can be effective alternative to ACEI in reducing albuminuria as proved by clinical trial.(15) The powerful effect of pentoxifylline in DN as it can affect several pathways implicated in pathogenesis of DN; it has hypoglycemic effect by decrease Significantly blood glucose, HbA1c and serum triglyceride, it also decrease pro inflammatory cytokines (TNF-α, IL-1, IL-6), reduce plasma level of malondialdehyde and increase glutathione level.(16)
Neutrophil Gelatinase-Associated Lipocalin (NGAL): is a 25-kDa protein belong to lipocalin superfamily. The urinary concentration of NGAL increase in renal tubular damage as a result of both diminished reabsorption and increased release from renal tubules into urine indicating both proximal and distal tubular damage respectively.(17) NGAL is not considered a marker of renal function but a marker of structural damage of renal tubules, its level can quantify the degree of tubular damage.(18) NGAL can be used as a precocious marker of therapeutic response by application of NGAL measurement in monitoring the effectiveness of a particular treatment and predicting different clinical outcomes in the course of renal diseases
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- * This is a randomized, controlled, prospective study. * Ninety diabetic nephropathy patients at stage 3(micro-albuminuria) will be divided into three groups as follow -Group 1: (n=30) control group will receive traditional therapy blood glucose lowering agent +RAAS blockade ACEI or ARBs for six months. * Group 2 :( n=30) will receive traditional therapy +tadalafil PO 20 mg every other day for six months. Group 3 :( n=30) will receive traditional therapy+ pentoxifylline PO 400 mg twice daily for six months.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –: (n=30) control group will receive traditional therapy blood glucose lowering agent +RAAS blockade ACEI or ARBs for six months. |
| Tadalafil group | Experimental | Drug: Tadalafil 20Mg Oral Tablet:( n=30) will receive traditional therapy +tadalafil PO 20 mg every other day for six months |
| pentoxifylline group | Experimental | Drug: Pentoxifylline 400 MG Oral Tablet:( n=30) will receive traditional therapy+ pentoxifylline PO 400 mg twice daily for six months. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A confirmed with clinical diagnosis of T2DM with duration at least 7 years to ensure established of micro-vascular complication (DKD).
- females (post-menopause), males with sufficient erectile function.
- Patients on stage 3 DN with evidence of persistent micro-albuminuria. All Abnormal tests of (UACR) must be confirmed in two out of three samples collected over a 6 month period before enrolled in the study.
- (urinary ACR≥30-300mg/g) in 3 consecutive measurements in 6 months period despite treatment with RAAS blockade(ramipril 10 mg ) ACEI or for at least 6 months period before enrollment in the study at maximum recommended tolerated dose.
- Exclusion Criteria:Cardiovascular disease: angina, arrhythmias, myocardial Infarction, heart failure (NYHA II -IV), uncontrolled hypertension > (170 \100 mm Hg) severe hypotension < (90\50 mm Hg), Hearing problem, vision defect, previous episodes of retinal / cerebral hemorrhage, psychiatric disease, thyroid disorders, alcohol abuse, smoking, Hepatic insufficiency (child -Pugh class C), (ALT or AST>3N), cholestasis, history of chronic inflammatory, immunologic or malignant disease. Acute inflammation or infectious disease in the previous 3 months, taking immunosuppressive treatment, Known allergy to tadalafil or methylxanthine, Use alpha one blockers, use of anti-oxidant drugs three months before enrollment in the study ,medications strongly alter CYP3A4 inducer or inhibitor, use of nitrates, other PDEI drugs, - Renal disease (acute kidney injury, recent exposure to radio- contrast media, creatinine clearance <30 ml/ min /1.73 m2 , bleeding disorders, peptic ulcer, and stroke, Pregnancy, lactation.
Key exclusion criteria (0 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 |
|---|---|---|
| Tadalafil 20Mg Oral TabletAlso: cialongTadalafil is a phosphodiesterase type 5 enzyme (PDE5) inhibitor used mainly in erectile dysfunction and pulmonary hypertension by a mechanism involving increase(NO-cGMP-PKG) signaling pathway.(8) Tadalafil is a powerful pleiotropic drug that it can be used in DN as it can target more than pathway involved in pathogenesis of DN include hyperglycemia and endothelial dysfunction through increase (NO-cGMP) signaling pathway as well as hyperlipidemia | Drug | Tadalafil group |
| Pentoxifylline 400 MG Oral TabletAlso: Pental SRPentoxifylline is a methyl xanthine derivative, non selective phosphodiesterase enzyme inhibitor used mainly to treat peripheral vascular diseases by improve blood flow | Drug | pentoxifylline group |
Primary outcome
Change in Urinary albumin/creatinine ratio (ACR)
Time frame: Change between baseline and six months after
Measurement of urine albumin to creatinne ratio by measurement of urine albumin using Turbidimetric immunoassay method and measurement of urine creatinnie by standard by enzymatic colorimetric methods
Change in Hemoglobin A1c (HbA1c).
Time frame: Change between baseline and six months after
Measurement of Hemoglobin A1C using (HPLC: ion exchange chromatography)
Change in Fasting blood glucose.
Time frame: Change between baseline and six months after
Measurement of Fasting blood glucose by using standard enzymatic colorimetric methods
Change in Sr Cr
Time frame: Change between baseline and six months after
Measurement of serum creatinine using colorimetric technique
Change in Creatinine clearance
Time frame: Change between baseline and six months after
Creatinine clearance was calculated by (Cockcroft-Gault Formula)
change in 2- Hours Postprandial blood glucose
Time frame: Change between baseline and six months after
Measurement 2- Hours Postprandial blood glucose in blood using standard enzymatic colorimetric methods
4 secondary outcomes
Change in serum ((TNF-α).
Time frame: Change between baseline and six months after
Change in Urinary NGAL (uNGAL).
Time frame: Change between baseline and six months after
Change in Lipid profile (TG, LDL, and HDL).
Time frame: Change between baseline and six months after
Change in serum malondialdehyde (MDA) .
Time frame: Change between baseline and six months after
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 14 May 2024.
- Background: PubMed 19200057Rivero A, Mora C, Muros M, Garcia J, Herrera H, Navarro-Gonzalez JF. Pathogenic perspectives for the role of inflammation in diabetic nephropathy. Clin Sci (Lond). 2009 Mar;116(6):479-92. doi: 10.1042/CS20080394.
- Background: PubMed 23075333Wada J, Makino H. Inflammation and the pathogenesis of diabetic nephropathy. Clin Sci (Lond). 2013 Feb;124(3):139-52. doi: 10.1042/CS20120198.
- Derived from this study: PubMed 38915115Hegazy SK, Amaar WA, Hegab WSM. Tadalafil versus pentoxifylline in the management of diabetic kidney disease: a randomized clinical trial. Diabetol Metab Syndr. 2024 Jun 24;16(1):138. doi: 10.1186/s13098-024-01363-3.
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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.
Wafaa S Hegab, Lecturer study chair
Tanta University
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 Tadalafil 20Mg Oral Tablet and Pentoxifylline 400 MG Oral Tablet in people with Diabetic Nephropathy Type 2, run by Tanta 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 0 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 14 May 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. 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?
Change in Urinary albumin/creatinine ratio (ACR) (time frame: Change between baseline and six months after). The study lists 6 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 NCT05487755, which also lists 3 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 14 May 2024.