Phase 2 Chronic Kidney Disease Trial, Recruiting NCT06794593 Sponsor: Odense University Hospital Condition: Chronic Kidney Disease
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Phase 2 Chronic Kidney Disease Trial, Recruiting

NCT06794593
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

For Patients with Chronic Kidney Disease (CKD):

Who might be able to join this trial:

  • People aged 18 or older
  • People who have been diagnosed with chronic kidney disease (CKD) of any cause, with kidney function and protein-in-urine levels within specific ranges at screening (confirm with trial site)
  • People who have been on a stable blood pressure medication routine for at least 2 weeks before the trial starts and can continue that routine throughout the study
  • People whose blood pressure at the screening visit falls within a specific range — not too high and not too low (confirm with trial site)
  • People who are able to understand and sign a consent form and follow the study requirements
  • Women who could become pregnant must have a negative pregnancy test at the screening visit and must use contraception during the study and for one week after the study treatment ends

Who may not be able to join:

  • People currently taking certain medications including Amiloride, Spironolactone, or Aldosterone (or similar drugs)
  • People currently taking anti-inflammatory painkillers known as NSAIDs (such as ibuprofen)
  • People with high potassium levels in their blood at screening
  • People with elevated bilirubin (a liver-related substance) in their blood at screening
  • People currently undergoing cancer treatment
  • People who have received immune-suppressing medications within the 6 months before screening
  • People who have had an organ transplant at any point
  • People showing signs of an active infection at the time of screening
  • People with severe liver disease (classified as Child-Pugh C)
  • People who are currently breastfeeding
  • People with severe or unstable heart failure
  • People who have had certain heart or cardiovascular events — such as a heart procedure, stroke, mini-stroke, or acute heart condition — within the 2 months before screening
  • People with a known allergy or sensitivity to the study medication
  • People with Addison's disease (a condition affecting the adrenal glands)
  • People who have had gastric bypass surgery
  • People with lactose intolerance, as the study medication contains lactose
  • People who have participated in another clinical trial within the last 30 days

For Healthy Volunteers:

Who might be able to join this trial:

  • People aged 18 or older
  • People in good general health with no significant medical conditions or chronic illnesses (such as diabetes, high blood pressure, heart disease, autoimmune diseases, or cancer)
  • People with normal kidney function and no protein detected in their urine at screening
  • People whose blood pressure at screening is below a specific threshold (confirm with trial site)
  • People who are able to understand and sign a consent form and follow the study requirements
  • Women who could become pregnant must have a negative pregnancy test at the screening visit and must use contraception during the study and for one week after the study treatment ends

Who may not be able to join:

  • People taking any prescription medication, with the exception of oral contraceptives
  • People currently taking anti-inflammatory painkillers known as NSAIDs (such as ibuprofen)
  • People with high potassium levels in their blood at screening
  • People with elevated bilirubin (a liver-related substance) in their blood at screening
  • People showing signs of an active infection at the time of screening
  • People who are currently breastfeeding
  • People with a history of substance abuse, including alcohol
  • People with a known allergy or sensitivity to the study medication
  • People who have had gastric bypass surgery
  • People with lactose intolerance, as the study medication contains lactose
  • People who have participated in another clinical trial within the last 30 days

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Claus Bistrup, MD, Professor, Department of Nephrology, Odense University Hospital, Denmark

Phone: +4523368077

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Odense University Hospital
Registry
ClinicalTrials.gov
Start date
21 November 2024
Est. completion
31 December 2025

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

24 h Urine sodium excretion (mmol/day); Water excretion (L); Total Body Water (L); Home blood pressure

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov