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Kidney cleanse? experimental drug aims to flush cholesterol from damaged kidneys

NCT ID NCT06489340

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial planned to test an experimental drug called VAR200 (2-HPβCD) in adults with type 2 diabetes and kidney disease. The drug works by removing extra cholesterol from kidney cells, which might help protect the kidneys. However, the study was withdrawn before any participants were enrolled, so no data was collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
2-hydroxypropyl-β-cyclodextrin (2-HPβCD)
What this could lead to
If it worked, this could point toward a new way to slow kidney damage in people with type 2 diabetes.
What could go wrong
The trial was withdrawn before enrolling anyone, so no results exist. It is very early-stage and may not be safe or effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Started

Jun 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Capable of giving and has provided a signed Informed Consent Form (ICF). 2. Male or female age 18 to 75 years inclusive, at the time of signing the informed consent. 3. Women of childbearing potential (WOCBP) and male subjects who are partners of WOCBP must agree to use an acceptable form of contraception during the study and for 30 days following the last dose of study drug. 4. Clinical diagnosis of type 2 diabetes as per guidelines. 5. Clinical diagnosis of diabetic kidney disease in the opinion of the principal investigator, or renal biopsy proven diabetic kidney disease without evidence of additional pathologic findings of alternative diagnosis. 1. At screening, based on two 24-hour urine collections, geometric mean of two urinary albumin creatine ratios (UACR) ≥ 400 mg/g and ≤ 3500 mg/g. 2. At screening, eGFR equal or greater than 30 and less than 90 mL/min/1.73 m\^2. 6. Body mass index (BMI) ≤ 40.0 kg/m\^2. 7. If on diabetes and anti-hypertensive medications: 1. Angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) inhibitors dose must be stable for 3 months before screening. 2. Sodium-glucose co-transporter 2 (SGLT2) or GLP-1 receptor agonist or long-acting insulin dose must be stable for at least 3 months prior to screening. 3. All other diabetes and anti-hypertensive medications must be at a stable dose for at least 3 months prior to screening. 8. Hemoglobin A1c (HbA1c) ≤10.0% at screening. 9. Willing to comply with IV administration of the study drug for 12 weeks and all protocol procedures during the study. Exclusion Criteria: 1. Has a solitary kidney. 2. Has a positive drug screen. 3. Known kidney disease other than diabetic kidney disease. 4. End stage renal disease (ESRD) (i.e., peritoneal dialysis, hemodialysis, or history of kidney transplantation). 5. Acute kidney injury or dialysis within the last 3 months before the screening visit. 6. Uncontrolled diabetes as defined by HbA1c \>10 at screening. 7. Uncontrolled hypertension with systolic blood pressure (SBP) \>140 mmHg or diastolic blood pressure (DBP) \>90 mmHg during screening. 8. Unstable cardiovascular disease or history of myocardial infarction or arterial thromboembolic events within 3 months prior to screening or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval \>480 msec. 9. Patients on IV medication containing cyclodextrin. 10. Patients on steroids, except for those on low-dose topical steroids (per PI discretion) or intranasal or inhaled steroids. 11. Surgery within the past 3 months prior to the first study drug administration determined by the Investigator to be clinically relevant. 12. Known malignancy that is progressing or has required active treatment within the past 3 years. Any exceptions must be approved by the Medical Monitor. a. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 13. Known history of Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies). 14. Known active Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. 15. Diabetic ketosis, ketoacidosis and severe infections within a month or active infection requiring systemic therapy. 16. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participants' participation for the full duration of the study, or is not in the best interest of the participants to participate in the opinion of the treating Investigator. 17. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. 18. Women participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study or within 30 days of participation. 19. Aspartate aminotransferase (AST) or alanine transaminase (ALT) \>3 upper limit of normal (ULN). One repeat test may be allowed within 7 days at the discretion of the Investigator. 20. Absolute neutrophil count ≤ 1.5 x 109/L at screening. 21. Platelets ≤ 100 x 109/L at screening. 22. Abnormal Hemoglobin (Hgb) (for men, abnormal levels are defined as \<11.0 grams per deciliter (gm/dL) or \>17.5 gm/dL. For women, \< 10.0 gm/dL or \>15.3 gm/dL.) 23. Currently participating or have participated in a study of an investigational product or used an investigational device within 3 months (or \> 3 half-lives for mAbs with prolonged half-life of greater than 30 days) prior to the first dose of study intervention. 24. Patients on antibody therapeutics. 25. History or presence of alcohol or drug abuse within the 1 year prior to the first study drug administration. 26. A known history of otologic disease (e.g., Meniere's, sudden hearing loss, fluctuating hearing loss, vestibular schwannoma). 27. Pure tone air conduction thresholds in either ear at 3 consecutive frequencies \> 60 dB at: 0.25, 0.5, 1, 2, 3, 4, 6, and 8 kHz. 28. Pure tone bone conduction thresholds \> 60 dB in either ear that are 10 dB better than air conduction thresholds (i.e., air-bone gap \> 10 dB) at all of the following frequencies: 0.5, 1, 2, and 4 kHz. 29. Use of non-steroidal anti-inflammatory drugs (NSAIDS) during the study period other than chronic low dose of aspirin stable for at least 3 months. 30. History of participation in a stem cell or gene therapy trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212, United States

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