Dapagliflozin on Renal Morphology and Renal Perfusion in Patients One Year After Kidney Transplantation

NCT06560801 | Recruiting Phase 4

• 1 other identifier: Dapa-TxV1.0
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to observe the mechanisms of dapagliflozin on the renal interstitial tissue and renal perfusion. For this purpose, renal transplanted patients as an excellent model of CKD and high cardiovascular risk (similar to patients in DAPA-CKD study) are included in this study. The objectives of the study are to analyze the effects of dapagliflozin on renal morphology and renal perfusion in patients with impaired renal function one year after kidney transplantation. This is a randomized (1:1), single centre clinical study. Each patient will be randomly assigned in an unblinded fashion to 10 mg Dapagliflozin or not 9 months after transplantation. At least 48 patients will be randomized and included. The routine renal biopsy taken one year after kidney transplantation will allow us to determine the morphological integrity of peritubular fibroblasts, interstitial inflammatory cell density and investigate markers of inflammation, oxidative stress and nitic oxide synthase expression (iNOS).

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (3)

• renal morphology - fibroblasts

  integrity of peritubular fibroblasts (PDGFRα) assessed from the routine one year follow up biopsy of the renal transplant

  3 months after randomization

• renal morphology - inflammation

  markers of inflammation (example CD3, CD68, CD163) in the interstitium from the routine one year follow up biopsy of the renal transplant

  3 months after randomization

• renal morphology - oxidative stress

  markers of oxidative stress (Nox1, 8-OHdG) in the interstitium assessed from the routine one year follow up biopsy of the renal transplant

  3 months after randomization

Secondary Outcomes (4)

• mRNA Expression profile of transcripts

  3 months after randomization

• renal perfusion

  3 months after randomization

• central (aortic) systolic pressurepulse pressure

  3 months after randomization

• pulse pressure

  3 months after randomization

Study Arms (2)

Dapagliflozin

ACTIVE COMPARATOR

Dapagliflozin + standard of care

Drug: Dapagliflozin 10mg Tab

Standard of care

NO INTERVENTION

standard of care only

Interventions

Dapagliflozin 10mg Tab DRUG

Randomization will take place at visit 1 to either the group receiving standard care and dapagliflozin or standard care only.

Dapagliflozin

Eligibility Criteria

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

You may qualify if:

• Female and male patients aged between 18 and 75 years
• Patients with renal transplant having a stable eGFR, who are in stable condition, 9 months after transplantation, irrespective of their diabetes status
• Females of child bearing potential must be using adequate contraceptive precautions
• Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
• Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form

You may not qualify if:

• Type 1 diabetes mellitus.
• HbA1c \> 10%
• Use of SGLT-2 inhibitor within the past 2 months
• eGFR \<25 ml/min/1.73m² (CKD-EPI Formula).
• Uncontrolled arterial hypertension (RR \> 180/110 mmHg).
• Congestive heart failure (CHF) NYHA stage IV.
• Recurrent urinary tract infections (bacterial or fungal)
• Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmacokinetics of the drug.
• Significant laboratory abnormalities such as SGOT or SGPT levels more than 5 x above the upper limit of normal range.
• Antihypertensives are allowed but should be kept stable throughout the study period.
• Statins and other antihyperlipidemic drugs are allowed but should be kept stable throughout the study period.
• Drug or alcohol abusus
• Pregnant or breast-feeding patients
• Patients with contraindications to MRI

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Clinical Research Center (CRC)

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Drug: dapagliflozin, other: standard of care

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 19, 2024
• Study Start: July 28, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)