Curcumin in Kidney Transplant Recipients

Not Applicable

Active, not recruiting

• Conditions: Disorder Related to Renal Transplantation
• Interventions: Other: Placebo; Dietary Supplement: Curcumin

• Registration Number: NCT03935958
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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.

Detailed Description

Kidney transplant recipients are at increased risk of death from cardiovascular disease (CVD). Inflammation, oxidative stress and vascular dysfunction (impaired endothelial function and increased large elastic artery stiffness), are highly prevalent in kidney transplant recipients and contribute to the high incidence of CVD in this patient population. The most common cause of kidney transplant failure is interstitial fibrosis and tubular atrophy (IFTA). The incidence of IFTA is as high as 50% of kidney transplants at 1 year after transplantation. The pathophysiology of IFTA is not well understood. Possible mechanisms include chronic rejection or injury, inflammation, and drug toxicity. Kidney transplant recipients suffer from high rates of cognitive decline for which the investigators lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction, and cognitive impairment are a priority.

Curcumin may have positive effects in terms of cardiovascular and nephroprotection because of its antibacterial, antiviral, anti-inflammatory and anti-oxidative effects. The aim of this study is to elucidate the role of curcumin as a nutritional strategy to reduce cardiovascular risk factors as well as inflammation and oxidative stress in kidney transplant recipients. The study aims to examine if curcumin will improve endothelial function by reducing markers of inflammation and oxidative stress. In addition, the study will evaluate the potential benefit of curcumin on cognitive function in kidney transplant recipients.

Curcumin is a natural polyphenol with anti-inflammatory and antioxidant characteristics. Preliminary data indicate that curcumin administration improves endothelial dysfunction by reducing oxidative stress and inflammation and may improve cognitive function.

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.

Objectives:

1. Evaluate the effects of curcumin on kidney transplant graft function

2. Evaluate the effects of curcumin supplementation on cognitive function.

3. Evaluate the effects of curcumin on diabetes and cardiovascular outcomes

4. Evaluate the effects of curcumin on systemic and endothelial cell markers of inflammation and oxidative stress.

Methods:

Patients will be randomized 1:1 to receive either curcumin or placebo starting at the time of transplant or up to 2 weeks prior to transplant. Patients will be followed per standard of care for kidney transplant recipients. Additional blood (30mL) and urine samples will be drawn prior to transplant and at 3, 6 and 12 months post-transplant to be used for future analysis. There will be a total of 4 visits for this study. Additionally, two questionnaires will be distributed at each visit.

Study Timeline

• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-02
• Study Start: 2019-11-01
• Primary Completion: 2023-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. The subject is a recipient of a living donor or deceased donor kidney only transplant
2. The subject is > 18 years of age

Exclusion Criteria

1. The subject has had a multi-organ transplant
2. Subjects that were taking curcumin pre-transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm (Arm 2)	Placebo	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 Arm (Arm 1)	Curcumin	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.

Primary Outcome Measures

Name	Time	Method
Graft Outcomes	12 months	Difference in biopsy scores at 3 and 12 months
Inflammation and oxidative stress	12 months	Markers of inflammation and oxidative stress at 0,3,6, \& 12 months
Cognitive function & Pain	12 months	Global Pain Scale at 0, 3, 6, and 12 months

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States