Phase 4 Chronic Kidney Disease Trial, Recruiting NCT06712407 Sponsor: Calliditas Therapeutics AB Condition: Chronic Kidney Disease
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Phase 4 Chronic Kidney Disease Trial, Recruiting

NCT06712407
Recruiting Phase 4

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

Who might be able to join this trial:

  • People who have been diagnosed with IgA nephropathy (a kidney condition), confirmed by a kidney biopsy
  • Adults aged 18 or older, of any gender
  • People who have already completed one full 9-month course of commercial TARPEYO® 16 mg (taken once daily), with that completion recorded at the study's starting visit
  • People for whom past laboratory test results are available, including at least one urine protein and kidney function test taken within 3 months before starting their commercial TARPEYO® treatment
  • People who have been on a stable dose of a blood-pressure-related kidney-protective medication (called a RAS inhibitor) or a medication called sparsentan for at least 8 weeks before the study's starting visit, with the dose not changing by more than 25%
  • People who, if currently taking a type of diabetes/kidney medication called an SGLT2 inhibitor, have been on a stable dose of it for at least 8 weeks before the study's starting visit, with the dose not changing by more than 25%

Who may not be able to join:

  • People who took systemic (whole-body) immune-suppressing medications or steroid medications — other than TARPEYO® itself — during their 9-month commercial TARPEYO® treatment period (note: steroid creams, inhalers, or inhaled immune-suppressing products are generally permitted)
  • People who have other types of kidney disease, such as C3 glomerulopathy, diabetic kidney disease, or kidney disease caused by high blood pressure
  • People who have nephrotic syndrome, a serious kidney condition involving very high protein in the urine and low protein levels in the blood
  • People whose medical condition makes continued TARPEYO® treatment unsuitable, as determined by the trial doctor
  • People who are currently on dialysis or who plan to start dialysis
  • People who have had a kidney transplant
  • People whose diabetes or high blood pressure is poorly controlled, as determined by the trial doctor
  • People with known osteoporosis that falls into the medium- or high-risk category based on specific medical guidelines (confirm with trial site)
  • People whose personal or medical circumstances make taking part in the trial or continuing TARPEYO® treatment unsuitable, as determined by the trial doctor
  • People with serious active infections that the trial doctor considers to pose a health risk
  • People who are unwilling or unable to follow the requirements of the trial
  • People who have taken another experimental drug either during this trial or during their preceding 9-month commercial TARPEYO® treatment period
  • People who are pregnant, breastfeeding, or planning to become pregnant during the trial period
  • People who are taking strong inhibitors of a liver enzyme called CYP3A4 (a group of medications that affect how the body processes certain drugs — confirm specific medications with the trial site)

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 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Krassimir Mitchev, Calliditas Therapeutics

Phone: 844-442-0011

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 4
Sponsor
Calliditas Therapeutics AB
Registry
ClinicalTrials.gov
Start date
17 December 2024
Est. completion
29 May 2026

Where this trial is recruiting

Puerto Rico 🇺🇸 United States

Primary endpoints

Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to Baseline

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: 27 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