Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?

NCT05788276 | Recruiting Phase 4 DMC

• 1 other identifier: 2022/426076
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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. Investigators will search for answers along three pathways: Can SGLT2 inhibitor 1) preserve glomerular filtration rate (GFR), 2) reduce interstitial fibrosis in the kidney, and 3) favorably improve metabolic risk factors for graft failure such as visceral obesity, glucose intolerance and high blood pressure? The participants (N=330) will be randomized to either dapagliflozin 10 mg or placebo o.d. in a blinded fashion. Researchers will than use kidney transplant biopsies, measured GFR, blood pressure sampling, glucose tolerance test (OGTT), dual-energy X-ray absorptiometry (DXA scan) and estimated GFR from the two groups in comparison, to evaluate the effect treatment. The participants will be followed for a total of 3 years.

Conditions

Kidney Transplant; Complications; Kidney Transplant Failure; Renal Failure

Keywords

Kidney; Transplantation; SGLT2; Renal function

Outcome Measures

Primary Outcomes (1)

• Effect of Dapagliflozin on the GFR slope in renal transplant patients (Main study)

  1\. Difference in eGFR slope between groups.

  From before randomization to 3 years after transplantation.

Secondary Outcomes (2)

• The effect of Dapagliflozin on renal and metabolic conditions between groups (Main study)

  From before randomization to 3 years after transplantation

• Changes in renal graft fibrosis and proteomic markers with SGLT2 inhibition between groups (Sub-study - the 140 first included patients).

  From before randomization to 3 years after transplantation

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

165 patients

Drug: Dapagliflozin 10mg Tab

Control group

PLACEBO COMPARATOR

165 patients

Drug: Placebo

Interventions

Dapagliflozin 10mg Tab DRUG

Dapagliflozin active tablets

Also known as: Active

Active treatment

Placebo DRUG

Matched placebo tablets

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 over the last 2 weeks.
• Estimated GFR ≥25 mL/min/1.73 m2.

You may not qualify 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.
• For women only - currently pregnant

Sponsors & Collaborators

• Oslo University Hospital: lead
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator
• Haukeland University Hospital: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0372, Norway

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Interventions

dapagliflozin; Exercise

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Trond Geir Jenssen, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trond Geir Jenssen, MD

CONTACT

0047 23073646; tjenssen@ous-hf.no

Charlotte Kongerud, MD

CONTACT

004723071917; ingkon@ous-hf.no

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chef Physician at Department of Organ Transplantation, Professor of Nephrology

Model Details: Randomized, Double blinded, placebo controlled interventional study

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 28, 2023
• Study Start: May 2, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)