Study on Renaparin for Improving Kidney Function in Patients with End-Stage Renal Disease Receiving Deceased Donor Transplants

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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 a 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 terms refer to potential complications that can occur when a kidney is transplanted, such as damage from a lack of blood flow or the kidney not working right away. The study will last for a total of 12 months, with the first 3 months being the main focus, followed by an additional 9-month follow-up period.

During the study, participants will be randomly assigned to receive either the Renaparin treatment or no treatment at all. The study is designed to be “single-blind,” meaning that the participants will not know which group they are in. Researchers will monitor the kidney function of participants by measuring various indicators, such as the estimated glomerular filtration rate (eGFR) and serum creatinine levels, at different points throughout the study. The goal is to determine if Renaparin can help improve these measures of kidney function in transplant recipients.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the treatment with Renaparin, and the other group will not receive any treatment. This process is called randomization and ensures that the study results are unbiased.

2 kidney transplantation

You will undergo a kidney transplantation procedure. The kidney you receive will be preserved using a solution containing Renaparin before the transplantation. This is done to improve the function of the transplanted kidney.

3 treatment period

During the first 3 months after your transplantation, the study will focus on assessing the effectiveness and safety of Renaparin in improving kidney function. You will be monitored closely during this period.

4 follow-up period

After the initial 3-month treatment period, there will be an additional 9-month follow-up phase. During this time, your kidney function will continue to be monitored to assess long-term outcomes.

5 monitoring and assessments

Throughout the study, your kidney function will be evaluated using various tests. These include measuring the estimated glomerular filtration rate (eGFR) and serum creatinine levels at specified intervals: Days 1-7, Day 30, and Months 3, 6, and 12.

The study will also track the incidence of delayed graft function (DGF), which refers to the need for dialysis within the first 7 days after transplantation, and other related outcomes.

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 an insufficient kidney function.
The patient must be dependent on dialysis, which means they have been receiving dialysis treatment for more than two months before the transplant.
The patient must be an acceptable candidate for a kidney transplant.
For female patients, they must be post-menopausal (no menstrual periods for 12 months without another medical reason), surgically sterile, or using effective methods of birth control during the study treatment. 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 (blocking of the fallopian tubes).
- Partner has had a vasectomy (surgical procedure for male sterilization).
The patient’s weight must be between 45 kg and 115 kg.
The patient must have a negative crossmatch test before the transplant, which means their blood is compatible with the donor’s blood, and there should be no evidence of donor-specific antibodies (antibodies that react against the donor’s cells).
The patient must be able to give informed consent, meaning they understand the study and agree to participate.

Who Cannot Join the Study?

Patients with end-stage renal disease or insufficient kidney function cannot participate. This means that if your kidneys are not working well enough, you cannot join the study.
Patients who are not within the specified age range cannot participate. The study is only for certain age groups.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care are not included.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Charite Research Organisation GmbH	Berlin	Germany
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
Mhapxjs Uxuwcspepa Ov Gsyg	Graz	Austria

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	31.08.2026
Germany	Not yet recruiting	31.08.2026

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 donor who has passed away, there is a risk that the kidney might not work as well right away. This is because the kidney can be damaged when it is taken out of the donor and put into the recipient. This damage is called ischemia-reperfusion injury, and it can lead to delayed graft function, meaning the kidney takes longer to start working properly. Renaparin is being tested to see if it can protect the kidney from this kind of damage and help it start working sooner and better 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 fluid 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 often necessitates renal replacement therapy, such as dialysis or kidney transplantation, to perform the functions of the failed kidneys.

Trial ID:

2022-501389-23-02

Protocol code:

RENAPAIR 02

Trial Phase:

Therapeutic exploratory (Phase II)

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