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New treatment option for Kidney Transplant; Complications
Official title Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
ClinicalTrials.gov ID: NCT05788276
What this study is testing
What is Dapagliflozin 10mg Tab?
Dapagliflozin 10mg Tab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for kidney transplant; complications.
Also referred to as Active.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to look at the effect of SGLT2 (Sodium glucose transporter 2) inhibition in patients receiving a kidney-transplant 6 weeks earlier at Oslo University hospital. Rikshospitalet.
- Phase 4: studies an already-approved treatment
- Time commitment: about 10 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Renal transplant recipients transplanted 6 weeks earlier at Oslo University hospital (OUH) Rikshospitalet.
- Age 18-75 years.
- Able to comply with the medical treatment on their own.
- Calcineurin inhibitor trough concentrations in accordance with individual therapeutic range and standard dose prednisolone and mycophenolate mofetil...
- Estimated GFR ≥25 mL/min/1.73 m2.
You likely can't join if
- Type 1 diabetes
- Rejection episodes of the kidney graft prior to randomization.
- Ongoing infectious disease or intermittent causes affecting renal function, e.g., obstructive lymphocele.
- Malnutrition.
- Urosepsis less than 1 year prior to randomization.
- Participants with a known hypersensitivity to dapagliflozin or any of the excipients of the product.
See the full eligibility criteria
- Renal transplant recipients transplanted 6 weeks earlier at Oslo University hospital (OUH) Rikshospitalet.
- Age 18-75 years.
- Able to comply with the medical treatment on their own.
- Calcineurin inhibitor trough concentrations in accordance with individual therapeutic range and standard dose prednisolone and mycophenolate mofetil over the last 2 weeks.
- Estimated GFR ≥25 mL/min/1.73 m2.
- Type 1 diabetes
- Rejection episodes of the kidney graft prior to randomization.
- Ongoing infectious disease or intermittent causes affecting renal function, e.g., obstructive lymphocele.
- Malnutrition.
- Urosepsis less than 1 year prior to randomization.
- Participants with a known hypersensitivity to dapagliflozin or any of the excipients of the product.
- For women only - currently pregnant
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Oslo, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.