The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation

2017-01-12 04:38:22 | BioPortfolio


This is a long-term intervention study on the effects of marine n-3 PUFAs in renal transplantation. Our hypothesis is that patients treated with marine n-3 PUFA supplementation will have less decline in kidney transplant function compared to patients treated with placebo.


The study is designed as a randomized, double blind, placebo controlled, multi-center trial of 174 renal transplant recipients. Patients will be randomized to oral supplementation of marine n-3 PUFA 2.5 g / day or control in a 1:1 fashion.

The primary endpoint is change in estimated glomerular filtration rate after 156 weeks in the treatment group compared with the control group. Secondary endpoints include the following variables: proteinuria, plasma inflammatory and fibrotic biomarkers, blood pressure, resting heart rate, fasting serum glucose / HbA1c, lipid and lipoprotein concentrations, number of graft rejections and graft losses, and number of cardiovascular events and deaths.

Patients from Akershus University Hospital will also participate in a sub-study, where renal graft biopsies will be performed to assess the degree of fibrosis and chronic allograft damage index (CADI) and markers of fibrosis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Kidney Transplantation


Omacor, Placebo Oral Capsule


Akershus University Hospital


Not yet recruiting


University Hospital, Akershus

Results (where available)

View Results


Published on BioPortfolio: 2017-01-12T04:38:22-0500

Clinical Trials [4893 Associated Clinical Trials listed on BioPortfolio]

The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation

The primary objective of this study is to compare the gut microbiota and clinical outcomes of oral FMT during antibiotic treatment, immediately following antibiotic treatment, and placebo....

Effect of Omacor on Triglycerides in HIV Infected Subjects

Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment

Omacor for the Treatment of Vascular Dysfunction in Patients With Type 2 Diabetes Mellitus

The purpose of the study is to determine whether a 6-week treatment with 4 g Omacor/day improves the baseline and postprandial endothelial function (after a high-fat meal) in patients with...

A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON

This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients w...

A Study To Test An Anti-Rejection Therapy After Kidney Transplantation

Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-re...

PubMed Articles [9959 Associated PubMed Articles listed on BioPortfolio]

The fallacy of pre-kidney transplantation "dental clearance".

Kidney transplantation in ANCA-associated vasculitis.

The kidney is commonly affected in patients with ANCA-associated vasculitis (AAV), causing end-stage renal disease (ESRD) in 20-40% of cases. Kidney transplantation is the treatment of choice for elig...

Pediatric kidney transplantation in Nepal.

Success in pediatric kidney transplantation is great achievement for the emerging countries. This report is the first of its kind from Nepal. It demonstrates the status of pediatric kidney transplanta...

Kidney after Liver Transplantation Matched-Pair Analysis: Are Kidneys Allocated to Appropriate Patients to Maximize Their Survival?

Kidney after liver transplantation (KALT) is the best therapeutic option for patients with end-stage renal disease after liver transplantation (OLT). New allocation policies prioritize kidneys to pati...

Predictors of return to work after kidney transplantation: a 12-month cohort of the Japan Academic Consortium of Kidney Transplantation study.

To investigate the cumulative return-to-work (RTW) rate and to identify predictors of employment after kidney transplantation (KT).

Medical and Biotech [MESH] Definitions

A double-walled epithelial capsule that is the bulbous closed proximal end of the kidney tubular system. It surrounds the cluster of convoluted capillaries of KIDNEY GLOMERULUS and is continuous with the convoluted PROXIMAL KIDNEY TUBULE.

The outer zone of the KIDNEY, beneath the capsule, consisting of KIDNEY GLOMERULUS; KIDNEY TUBULES, DISTAL; and KIDNEY TUBULES, PROXIMAL.

Long convoluted tubules in the nephrons. They collect filtrate from blood passing through the KIDNEY GLOMERULUS and process this filtrate into URINE. Each renal tubule consists of a BOWMAN CAPSULE; PROXIMAL KIDNEY TUBULE; LOOP OF HENLE; DISTAL KIDNEY TUBULE; and KIDNEY COLLECTING DUCT leading to the central cavity of the kidney (KIDNEY PELVIS) that connects to the URETER.

The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.

The transference of a kidney from one human or animal to another.

More From BioPortfolio on "The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation"

Quick Search

Relevant Topics

Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...

Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...

Searches Linking to this Trial