Liposomal Curcumin for Kidney Disease

Overseen By Sofia Acevedo, BS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Florida

Disqualifiers: CKD stages 1-4, Peritoneal dialysis, Pregnant, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 25

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether liposomal curcumin, a form of the spice turmeric, can reduce inflammation and oxidative stress in individuals with severe kidney disease undergoing hemodialysis. Participants will receive either a high-protein product with curcumin or a similar product without it for 8 weeks. The trial aims to determine if curcumin can improve blood health markers and enhance quality of life. It suits adults with advanced kidney disease (stage 5) who have been on hemodialysis for at least three months and have no dietary restrictions. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that liposomal curcumin is likely to be safe for humans?

Research shows that liposomal curcumin is generally safe for humans. Studies have found curcumin beneficial for kidney health, helping to reduce inflammation and harmful substances that can damage the kidneys.

Most people tolerate curcumin well. Some studies found it lowered cholesterol and a protein linked to inflammation in people with chronic kidney disease, suggesting it can improve kidney function without major side effects.

The current trial is in an advanced phase, indicating the treatment has already passed earlier safety tests and is considered safe enough for more participants. However, as with any treatment, individual reactions can vary. Prospective participants should discuss potential risks with a healthcare professional. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney disease?

Unlike standard treatments for kidney disease, which often focus on managing symptoms or delaying progression through medications like ACE inhibitors and ARBs, liposomal curcumin offers a novel approach. This treatment utilizes curcumin, the active ingredient in turmeric, known for its anti-inflammatory and antioxidant properties. Researchers are particularly excited about its delivery method; by encapsulating curcumin in liposomes, it potentially enhances absorption and bioavailability, making it more effective. This new mechanism could address inflammation at a cellular level, offering hope for improved kidney function and patient outcomes.

What evidence suggests that liposomal curcumin might be an effective treatment for kidney disease?

Research shows that liposomal curcumin, which participants in this trial may receive, might help improve kidney function. Studies have found that curcumin can lower inflammation and reduce stress in people with chronic kidney disease. In some cases, curcumin has matched certain medications in reducing harmful proteins and inflammation in the kidneys. Some patients have seen improvements in kidney health after using curcumin for more than eight weeks. While these results are promising, it's important to note the risk of kidney damage during treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Jeanette M Andrade, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

Adults over 18 with stage 5 chronic kidney disease (CKD) who have been on hemodialysis for at least three months can join. They must be able to sign consent, have no dietary restrictions, food allergies, or problems with chewing/swallowing.

Inclusion Criteria

I can sign a consent form, have no food allergies, dietary restrictions, or problems with eating.

I have been diagnosed with stage 5 chronic kidney disease.

I have been on hemodialysis for at least three months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment

Participants receive 38 g of high protein product with or without 7 mls of liposomal curcumin at the end of each dialysis session, 3 days a week for 8 weeks

8 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood samples collected to assess carryover effects

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Liposomal Curcumin

Trial Overview The trial is testing if a high-protein oral supplement with liposomal curcumin helps reduce inflammation and oxidative stress in adults undergoing hemodialysis. It's a 12-week study where participants are randomly assigned to receive the supplement with or without curcumin.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants will consume 38 g of high protein product with 7 mls of curcumin at the end of each dialysis session, 3 days a week for 8 weeks for a total of 24 treatments.

Group II: Control Placebo Group 1 Intervention

Participants will consume 38 g of high protein product that contains an orange food colorant at the end of each dialysis session, 3 days a week for 8 weeks for a total of 24 treatments.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Curcumin, a natural compound from the Curcuma longa plant, has demonstrated significant renoprotective effects in various experimental models of kidney injury, including diabetic nephropathy and chronic renal failure.

The protective effects of curcumin are linked to its ability to induce antioxidant responses, preserve mitochondrial function, and reduce inflammation, making it a promising therapeutic agent for preventing renal damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renoprotective effect of the antioxidant curcumin: Recent findings. Trujillo, J., Chirino, YI., Molina-Jijón, E., et al.[2022]

Curcumin intake significantly reduced total cholesterol levels and tumor necrosis factor alpha (TNF-α) in patients with chronic kidney disease, indicating its potential anti-inflammatory and lipid-lowering effects.

The meta-analysis included nine studies, showing that while curcumin had a positive impact on total cholesterol and TNF-α, it did not significantly affect triglycerides, LDL, HDL, or C-reactive protein levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of curcumin-containing supplementations on inflammatory markers and lipid profiles in patients with chronic kidney diseases: a systematic review and meta-analysis of randomized controlled trials. Futuhi, F., Naghibzadeh Tahami, A., Azmandian, J., et al.[2022]

In a randomized, double-blind, placebo-controlled trial involving 533 adults with chronic kidney disease (CKD), micro-particle curcumin (90 mg/day) did not significantly reduce albuminuria or slow the decline in kidney function over a 6-month period.

The study found no meaningful differences in changes in albuminuria or estimated glomerular filtration rate (eGFR) between the curcumin and placebo groups, suggesting that this formulation of curcumin may not be effective for managing CKD progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of micro-particle curcumin on chronic kidney disease progression: the MPAC-CKD randomized clinical trial. Weir, MA., Walsh, M., Cuerden, MS., et al.[2023]

In a randomized, placebo-controlled study of 24 patients with relapsing or refractory lupus nephritis, oral curcumin supplementation significantly reduced proteinuria, hematuria, and systolic blood pressure over a 3-month period.

No adverse effects were reported from curcumin supplementation, suggesting it is a safe adjuvant therapy for patients with lupus nephritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral supplementation of turmeric decreases proteinuria, hematuria, and systolic blood pressure in patients suffering from relapsing or refractory lupus nephritis: a randomized and placebo-controlled study. Khajehdehi, P., Zanjaninejad, B., Aflaki, E., et al.[2022]

In a pilot study involving 24 chronic kidney disease (CKD) patients, curcumin supplementation for six months significantly reduced pro-inflammatory markers and improved gut microbiota composition, suggesting potential benefits for CKD management.

The study reported no adverse events, indicating that curcumin has a good safety profile for long-term use in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin Supplementation (Meriva®) Modulates Inflammation, Lipid Peroxidation and Gut Microbiota Composition in Chronic Kidney Disease. Pivari, F., Mingione, A., Piazzini, G., et al.[2022]

Curcumin, a safe and inexpensive compound from turmeric, shows promise in treating renal fibrosis by reducing inflammation and extracellular matrix deposition in animal models.

The antifibrotic effects of curcumin are linked to its ability to lower inflammatory factors and activate anti-inflammatory pathways, targeting key signaling pathways involved in kidney health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Advances of Curcumin in the Prevention and Treatment of Renal Fibrosis. Sun, X., Liu, Y., Li, C., et al.[2022]

In a study involving 28 hemodialysis patients, 12 weeks of curcumin supplementation significantly reduced plasma levels of the inflammatory marker TNF-α, indicating its potential anti-inflammatory effects in chronic kidney disease.

The study supports the hypothesis that curcumin can help mitigate inflammation in patients undergoing hemodialysis, which may improve their overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin supplementation improves oxidative stress and inflammation biomarkers in patients undergoing hemodialysis: a secondary analysis of a randomized controlled trial. Alvarenga, L., Cardozo, LFMF., Da Cruz, BO., et al.[2022]

Curcumin demonstrated therapeutic effects in two mouse models of kidney disease, significantly reducing symptoms like proteinuria and blood urea nitrogen, indicating its potential to improve both acute and chronic kidney injury.

The study found that curcumin treatment lowered the activation of key inflammatory pathways (NFkB, MAPK, AKT, and pBAD), suggesting a mechanism by which it exerts its immunomodulatory and anti-inflammatory effects in kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin Attenuates Both Acute and Chronic Immune Nephritis. Wu, T., Marakkath, B., Ye, Y., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1756464622004662

The effect of curcumin supplementation on renal function The available data suggest that supplementation of bioavailability-boosted curcumin for more than 8 weeks prevents end-stage kidney disease, particularly in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6271001/

Curcumin and Chronic Kidney Disease (CKD) - PubMed Central We demonstrated that curcumin was as effective as enalapril in reducing the inflammatory cytokines TNFα and IL-1β and effectively abated both proteinuria and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7926985/

Protective Effects of Liposomal Curcumin on Oxidative ... Despite its high effectiveness, nephrotoxicity must be considered since renal failure is reported in 10–20% of cases during therapy [10].

4. withpower.com withpower.com/trial/phase-kidney-diseases-7-2024-1652e

Liposomal Curcumin for Kidney Disease · Info for Participants Studies have found that curcumin can lower inflammation markers and improve kidney function in both animal models and small human trials.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06381076?term=AREA%5BConditionSearch%5D(chronic%20inflammation)%20AND%20AREA%5BInterventionSearch%5D(curcumin)&rank=5

High-protein Oral Supplement With Liposomal Curcumin in ... Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis.

6. jrenendo.com jrenendo.com/PDF/jre-8-e23063.pdf

Therapeutic effects of curcumin on kidney disease Curcumin, which has antioxidant and anti-inflammatory abilities, can alleviate kidney damage and treat kidney disease. The safety of curcumin has been shown in ...