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Trial · Interventional

Status unknownNot applicableRegistry data

Semaglutide's Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy

Short name Sema-RMA

NCTNCT06555146 (opens ClinicalTrials.gov in a new tab)Other idH-20036378
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
15 participants (estimated)
Sponsor
Bispebjerg Hospital · Other
Design
Randomized · Double masking
Countries
1 country

Denmark

Start
Aug 2024 (estimated)
Primary completion
Mar 2025 (estimated)
Completion
Mar 2025 (estimated)
First posted
15 Aug 2024
Last update posted
15 Aug 2024
Conditions
Diabetes Mellitus, Type 2 · Kidney Disease, Chronic

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. N/A

    Sema-RMA

    NCT06555146

    est. Aug 2024 to est. Mar 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The goal of this double-blinded, placebo-controlled, randomized, crossover study is to examine the effect of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), on renal hemodynamics and function in patients with type 2 diabetes mellitus (T2DM) and moderate chronic kidney disease (CKD). The study will determine the effects of semaglutide on: * Renal arterial blood flow, regional renal perfusion, and oxygenation * Activity of the renin-angiotensin-aldosterone system (RAAS) * The glomerular filtration rate (GFR) * Sodium excretion in urine * Blood pressure and heart rate

Interventions

  • Semaglutide, 0.5 mg/mLDrug
  • Placebo, SalineDrug

Arms2

  • Other

    Randomized to start with Semaglutide intervention in study period 1

    Placebo will be given in study period 2

  • Other

    Randomized to start with Placebo intervention in study period 1

    Semaglutide will be given in study period 2

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Total blood flow

    Time frame · Measured during 30 minutes of MRI. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year).

    Registry description

    Volume of blood per unit time, ml/min

  2. Regional renal perfusion

    Time frame · Measured during 30 minutes of MRI. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year)

    Registry description

    volume of blood per unit time per unit tissue mass, ml/min/g

Secondary outcomes(5)

  1. Glomerular filtration rate

    Time frame · Measured with Tec99-DTPA clearance. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year)

    Registry description

    Volume per unit time, ml/min

  2. Sodium excretion in urine

    Time frame · One measurement will be done on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)

    Registry description

    Concentration, mmol/l

  3. Activation of the renin angiotensin aldosterone system

    Time frame · Blood samples will be taken 3 times on each intervention day, a total of 6 measurements for each participant, over the span of the study (approximately 1 year)

    Registry description

    Concentration, mmol/l

  4. Blood pressure

    Time frame · Measured continuously during a 60 minute period on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)

    Registry description

    mmhg

  5. Heart Rate

    Time frame · Measured continuously during a 60 minute period on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)

    Registry description

    Beats pr. minute

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results
Source linkSee results (15)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 20 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 2 diabetes mellitus diagnosed through either HbA1c ≥6,5% but ≤8,5%, or \<6,5% combined with either fasting plasma glucose ≥7,0 mmol/L or plasma glucose ≥11,1 mmol/L two hours after an oral glucose tolerance test (OGTT). * Estimated glomerular filtration rate (eGFR, CKD-EPI) between 30-60 mL/min/1.73m2 * Urine Albumin:Creatinine ratio (UACR) ≥30mg/g * Stable RAAS blockade (ACE inhibitors or angiotensin II receptor blocker (ARB) with stable dosis for 4 weeks prior to screening) * Discontinuation of treatment with selective sodium glucose transporter inhibitors (SGLT2i), dipeptidyl peptidase 4 inhibitors (DPP-4i), GLP-1R analogs, rapid-acting and mix insulin 30 days before screening. Exclusion Criteria: * Immunosuppressive therapy within 30 days of screening * Alcohol abuse * Medical treatment with glucocorticoids * Kidney transplantation * Treatment for renal failure with dialysis * Myocardial infarction within 3 months of screening * Heart failure (NYHA 3-4) * Dysregulated arterial hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥ 100 mm Hg) * Liver disease (ALAT \>2 x normal value) * Conditions which may interfere with the glucose metabolism according to the PI * Severe claustrophobia * Elements incompatible with MRI * Abnormal kidney size and/or position * Venous and arterial anatomy hindering catheterization.

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