Curcumin for Renal Transplant Health

Overseen By Natalie Isho, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Multi-organ transplant, Pre-transplant curcumin

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether curcumin, a natural compound in turmeric, can benefit kidney transplant recipients. Specifically, the researchers aim to determine if curcumin can improve blood vessel function and enhance brain health in these patients. Participants will receive either curcumin or a placebo (a substance with no active treatment) for one year. Individuals who have had a kidney-only transplant and are not currently taking curcumin may be suitable candidates for this study. As an unphased trial, this study provides participants the chance to contribute to groundbreaking research that could improve post-transplant care.

Do I have to stop taking my current medications for the trial?

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

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

Research has shown that curcumin is generally safe for people. One study on kidney health found that taking a special form of curcumin, which the body absorbs better, for over eight weeks helped prevent serious kidney disease. This suggests curcumin might be safe for the kidneys.

Another study found that taking 90 milligrams of a tiny particle form of curcumin daily for six months didn't cause harm, although it also didn't stop kidney problems from worsening. This indicates that curcumin didn't create new issues for the participants.

Overall, these studies suggest that curcumin is safe for people, including those with kidney concerns. However, as with any treatment, monitoring for side effects and consulting a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for maintaining renal transplant health, such as immunosuppressive drugs, curcumin is a natural compound derived from turmeric known for its anti-inflammatory and antioxidant properties. Researchers are excited about curcumin because it offers a potentially safer alternative with fewer side effects, as it targets inflammation and oxidative stress, which are key factors in transplant rejection. Additionally, curcumin's unique mechanism of action means it could complement existing therapies, potentially improving long-term transplant success rates without the harsh side effects associated with traditional medications.

What evidence suggests that curcumin might be an effective treatment for kidney transplant recipients?

Research shows that curcumin, a substance in turmeric, may benefit kidney transplant patients. Early findings suggest it can improve blood vessel function by reducing stress and swelling in the body. Curcumin might also aid in addressing thinking and memory problems, which are common among these patients. Studies indicate it has properties that support kidney health. In this trial, participants in the Curcumin Arm will receive curcumin for a year to further evaluate these potential benefits. While some results are encouraging, curcumin's effects can vary, and more research is needed to fully understand its benefits for kidney transplant patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Pierpaolo Di Cocco, MD, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have received a kidney transplant from either a living or deceased donor. It's not open to those who've had multiple organ transplants or were taking curcumin before their kidney transplant.

Inclusion Criteria

I have received a kidney transplant from a living or deceased donor.

I am older than 18 years.

Exclusion Criteria

I was taking curcumin before my transplant.

I have had a transplant involving multiple organs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive either curcumin or placebo starting at the time of transplant or up to 2 weeks prior, with follow-up visits at 0, 3, 6, and 12 months post-transplant

12 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with additional blood and urine samples collected for future analysis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Curcumin

Trial Overview The study is testing if curcumin can help improve blood vessel function and brain health in people who have had a kidney transplant, comparing it with a placebo (a substance with no therapeutic effect).

How Is the Trial Designed?

Group I: Curcumin Arm (Arm 1) Experimental Treatment 1 Intervention

20 subjects will be randomized (1:1) to this arm and receive curcumin for a year. In addition, subjects will have four study visits at Day 0, and 3, 6 and 12 months post-transplant. These study visits also include blood samples and questionnaires.

Group II: Placebo Arm (Arm 2) Placebo Group 1 Intervention

20 subjects will be randomized (1:1) to this arm and receive placebo for a year. In addition, subjects will have four study visits at Day 0, and 3, 6 and 12 months post-transplant. These study visits also include blood samples and questionnaires.

Curcumin is already approved in United States, European Union, India, China for the following indications:

Approved in United States as Curcumin for:

• Dietary Supplement

Approved in European Union as Curcuma for:

• Herbal Medicinal Product

Approved in India as Haldi for:

• Traditional Medicine

Approved in China as Jiang Huang for:

• Traditional Chinese Medicine

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Verdure Sciences

Industry Sponsor

Trials

5

Recruited

90+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03935958

NCT03935958 | Curcumin in Kidney Transplant Recipients Preliminary data indicate that curcumin administration improves endothelial dysfunction by reducing oxidative stress and inflammation and may improve cognitive ...

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6299333/

Micro-Particle Curcumin for the Treatment of Chronic Kidney ... Curcumin, a component of the dietary spice turmeric, has proven anti-inflammatory and anti-fibrotic properties (Supplement Figure S1) and has been shown to ...

4. academic.oup.com academic.oup.com/ndt/article/38/10/2192/7059224

effect of micro-particle curcumin on chronic kidney disease ... Ninety milligrams of micro-particle curcumin daily did not slow the progression of albuminuric CKD over 6 months.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20565374/

Clinical relevance of curcumin-induced ... In this study, we assessed the immunosuppressive potential of curcumin, a pharmacologically safe and cost-effective naturally occurring polyphenolic ...

6. ajkd.org ajkd.org/article/S0272-6386(20)30794-0/fulltext

Use of Dietary Supplements in Living Kidney Donors Though the prevalence and risks of dietary supplement use have been previously discussed in transplant recipients, with reported use between 35% ...