Effects Dapagliflozin on Inflammatory Markers Erythropoiesis and Iron Metabolism in Patients with Type 2 Diabetes and CKD
English Title of Research Project: Effects of Dapagliflozin on Inflammatory Markers, Erythropoiesis and Iron Metabolism in Patients with Type 2 Diabetes and CKD
1 other identifier
interventional
210
0 countries
N/A
Brief Summary
the effect of Dapagliflozin on erythropoiesis, iron metabolism and inflammatory markers in CKD with Type 2 DM-Compare between effect of placebo and dapagliflozin on erythropoiesis, iron metabolism and inflammation markers in CKD with Type 2 DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
ExpectedFebruary 11, 2025
February 1, 2025
1 year
February 6, 2025
February 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
GFR in CKD patients
Measure eGFR using ckd epi equation to detect the effect of dapagliflozin in improvement of GFR in CKD patients
6 months
Study Arms (2)
Group A
ACTIVE COMPARATORtype 2 diabetic patients with chronic kidney diseases will recive dapagliflozin
Group B
PLACEBO COMPARATORtype 2 diabetic patients with chronic kidney diseases will recive placebo
Interventions
patient will recive dapagliflozin for 24 week to improvement of eGFR on CKD patients
type 2 diabetic patients with chronic kidney diseases will recive placebo for 24 weeks
Eligibility Criteria
You may qualify if:
- Eligible participants were aged \>18 years and diagnosed with Type 2 diabetes participants we required to have urinary albumin-creatinine ratio (UACR ) of 30\_3500 mg /g ,eGFR of 20\_ 80 ml/min/ 1.73 m , and HbA1c of 7.0 \_ 11.0 % at screening
You may not qualify if:
- type 1 diabetes, non-diabetes kidney disease and patient with HB \< 9
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Koshino A, Neuen BL, Jongs N, Pollock C, Greasley PJ, Andersson EM, Hammarstedt A, Karlsson C, Langkilde AM, Wada T, Heerspink HJL. Effects of dapagliflozin and dapagliflozin-saxagliptin on erythropoiesis, iron and inflammation markers in patients with type 2 diabetes and chronic kidney disease: data from the DELIGHT trial. Cardiovasc Diabetol. 2023 Nov 28;22(1):330. doi: 10.1186/s12933-023-02027-8.
PMID: 38017482BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mai Mostafa, MD
professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- residant doctor
Study Record Dates
First Submitted
February 6, 2025
First Posted
February 11, 2025
Study Start
March 1, 2025
Primary Completion
March 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
February 11, 2025
Record last verified: 2025-02