Study on Renaparin for Improving Kidney Function in Transplant Patients with End-Stage Renal Disease from Deceased Donors

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called Renaparin on patients who have received a kidney transplant from a deceased donor. The study is particularly interested in patients with end-stage renal disease, which means their kidneys are no longer able to function properly. The treatment involves using a special solution, known as Renaparin, to help preserve the kidney before it is transplanted. This solution contains an active substance called Corline Heparin Conjugate, which is designed to improve the function of the transplanted kidney.

The purpose of the study is to see if Renaparin can help improve the function of the transplanted kidney, especially in patients who are at high risk of experiencing problems like ischemia-reperfusion injury and delayed graft function. These are conditions that can occur when the blood supply to the kidney is temporarily reduced or stopped, and then restored, which can sometimes damage the kidney. The study will last for a total of 12 months, with the first 3 months being the main focus, followed by a 9-month follow-up period.

During the study, some patients will receive the Renaparin treatment, while others will not receive any treatment, allowing researchers to compare the results. The study will monitor various aspects of kidney function, such as how well the kidney filters waste from the blood, and how often patients need dialysis, which is a treatment that helps clean the blood when the kidneys are not working well. The goal is to determine if Renaparin can help improve these outcomes for patients who have received a kidney transplant.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. You will be asked to provide informed consent, confirming your understanding and willingness to participate.

2 kidney transplantation

You will undergo a kidney transplantation procedure. The kidney must come from a deceased donor who is at least 18 years old. The donor kidney will be preserved using a special solution called Renaparin.

3 treatment with Renaparin

The donor kidney will be treated with Renaparin, a solution used for organ preservation. This is done to improve the function of the transplanted kidney.

4 monitoring kidney function

Your kidney function will be closely monitored for three months. This includes measuring the estimated glomerular filtration rate (eGFR) at the end of the third month. eGFR is a test that checks how well your kidneys are working.

5 additional follow-up

After the initial three months, there will be an additional follow-up period of nine months. During this time, your kidney function will continue to be assessed at various intervals, including serum creatinine levels and eGFR on specific days and months.

6 completion of the study

The study will conclude after a total of twelve months. Your participation will help assess the effectiveness and safety of Renaparin in improving kidney graft function.

Who Can Join the Study?

The patient must be between 18 and 75 years old.
The patient must have end-stage renal disease or otherwise insufficient kidney function.
The patient must be dependent on dialysis (a treatment that does the work of the kidneys) for more than two months before the transplant.
The patient must be an acceptable candidate for a kidney transplant.
Female patients must be post-menopausal, surgically sterile, or using effective birth control methods during the study treatment (3 months). Acceptable methods include:
- Combined hormonal contraception (oral, intravaginal, transdermal) that prevents ovulation.
- Progestogen-only hormonal contraception (oral, injectable, implantable) that prevents ovulation.
- Intrauterine device (IUD).
- Intrauterine hormone-releasing system.
- Bilateral tubal occlusion (surgical procedure to block fallopian tubes).
- Partner with a vasectomy (surgical procedure for male sterilization).
The patient’s weight must be between 45 and 115 kg.
The patient must have a negative crossmatch test (a test to check compatibility with the donor) before the transplant and no evidence of donor-specific antibodies.
The patient must be able to give informed consent to participate in the study.

Who Cannot Join the Study?

Patients with end-stage renal disease or those who have insufficient kidney function cannot participate. This means if your kidneys are not working well enough, you cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Medizinische Universitaet Innsbruck	Innsbruck	Austria

Other Sites

Site Name	City	Country	Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Charite Research Organisation GmbH	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	02.01.2023
Germany	Not yet recruiting	02.01.2023

Trial locations

Investigated drugs:

Corline Heparin Conjugate

Renaparin® is a medication being studied to see if it can help improve the function of a new kidney after a transplant. When someone receives a kidney from a deceased donor, there is a risk that the kidney might not work well right away. This is called delayed graft function. Renaparin® is being tested to see if it can protect the kidney from damage that can happen when blood flow returns to the kidney after it has been without blood for a while. This type of damage is known as ischemia-reperfusion injury. The study aims to find out if Renaparin® can help the kidney start working better and faster after the transplant.

End-stage renal disease – End-stage renal disease is the final stage of chronic kidney disease, where the kidneys can no longer function adequately to meet the body’s needs. This condition results in the accumulation of waste products and excess fluids in the body, leading to symptoms such as fatigue, swelling, and difficulty concentrating. As the disease progresses, the kidneys lose their ability to filter blood, regulate electrolytes, and maintain fluid balance. Patients may experience a decrease in urine output and require interventions to manage these symptoms. The progression of this disease can lead to complications affecting other organs and systems in the body.

Trial ID:

2022-501389-23-00

Protocol code:

RENAPAIR 02

Trial Phase:

Therapeutic exploratory (Phase II)

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