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

14 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary goal of this study is to investigate if curcumin is beneficial for kidney transplant recipients, a population with extensive baseline vascular dysfunction and cognitive impairment who have few treatment options. The possible mechanisms by which curcumin improves vascular function will be evaluated as well as whether curcumin improves cognitive function in these patients.

Research Team

Pierpaolo Di Cocco, MD, PhD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+