#1 Clinical Trials Search in Europe

Valganciclovir Hydrochloride

Clinical trials of Valganciclovir Hydrochloride are studying its use in kidney transplant patients, especially to help prevent or manage cytomegalovirus (CMV) infection. The trials look at safety, effectiveness, and transplant outcomes in different patient groups, including low-risk renal transplant patients and kidney transplant recipients receiving immune-based therapy.

Table of Contents

Trial overview

The provided clinical trial data show two authorised studies involving Valganciclovir Hydrochloride in kidney transplant care.[1][2] One study is a Phase 1 trial in kidney transplant recipients looking at safety and tolerability of a cell therapy added to standard immunosuppressive treatment, and Valganciclovir-ratiopharm® is listed among the background medicines.[1] The other is a Phase 3 study in low-risk renal transplant patients comparing immune-guided prevention with preemptive therapy for CMV infection, using Valganciclovir Normon as one of the study drugs.[2]

Phase 1 transplant safety study

The Phase 1 study, NCT 2024-514398-23-00, is an interventional trial with 27 participants and is authorised.[1] It studies deceased donor kidney transplant recipients and examines whether giving polyclonal ex-vivo expanded autologous Tregs, also called regulatory T cells, is safe as an extra treatment alongside standard immunosuppression.[1] This study is mainly about safety and tolerability, not about proving a final treatment benefit.[1]

The primary clinical endpoint is biopsy-confirmed acute rejection within 60 weeks after organ transplantation, which means rejection of the new kidney must be proven by a tissue sample from the transplant.[1] The trial also tracks acute toxicity, over-suppression of the immune system, and chronic toxicity related to the Treg02 infusions.[1] In the safety plan, the study specifically watches for major infections, including CMV, EBV, and polyomavirus reactivation or disease, as well as early neoplasia, which means early cancer growth.[1]

Valganciclovir-ratiopharm® 450 mg tablets are listed among the medicines used in this trial’s treatment context.[1] The trial data do not say that Valganciclovir Hydrochloride is the main study target here, but it is part of the transplant treatment background in this safety study.[1]

Phase 3 CMV prevention study

The Phase 3 study, NCT 2025-520742-29-00, is also authorised and includes 170 low-risk renal transplant patients.[2] It is called the INMUNOVIR Study and compares immune-guided prevention of CMV infection with preemptive therapy after kidney transplantation.[2] This is a later-phase study, so it is designed to compare how well the approaches work and how safe they are in a larger patient group.[2]

The main efficacy outcome is the proportion of patients who develop CMV disease at 6 and 12 months after transplantation.[2] CMV is a virus that can cause illness after transplant, especially when patients take medicine that lowers the immune system.[2] The main safety outcome is the proportion of patients with different degrees of neutropenia at 6 and 12 months after transplantation.[2]

In this study, Ganciclovir Accord is given by infusion and Valganciclovir Normon 450 mg tablets are given by mouth.[2] The trial brief says it compares immune-guided prophylaxis with preemptive therapy in kidney transplant recipients.[2]

Who the trials include

The two trials focus on different kidney transplant populations.[1][2] The Phase 1 study includes deceased donor kidney transplant recipients, meaning the kidney comes from a person who has died.[1] The Phase 3 study includes low-risk renal transplant patients, which means patients judged to have a lower risk group in the transplant setting.[2]

  • Deceased donor kidney transplant recipients: people who received a kidney from a deceased donor and are being followed for safety and rejection outcomes.[1]

  • Low-risk renal transplant patients: people after kidney transplant who are considered lower risk and are being studied for CMV prevention strategies.[2]

What the trials measure

The Phase 1 trial measures several safety endpoints related to the Treg02 infusion.[1] These include acute toxicity, immune over-suppression, and chronic toxicity.[1] The trial looks for pulmonary complications, severe immune reactions such as anaphylaxis, immediate cardiovascular compromise, other acute organ failure, infections, early cancer, autoimmune disorders, inflammatory pathologies, anaemia, cytopenia, and biochemical anomalies not explained by the transplanted kidney’s function.[1]

The Phase 3 trial measures two main outcomes at 6 and 12 months after transplantation.[2] The first is CMV disease, which shows whether the prevention strategy works.[2] The second is neutropenia, which helps show whether the treatment causes a drop in white blood cells that could raise infection risk.[2]

Key patient-focused points

These studies are not general drug information studies; they are transplant research studies looking at real patient outcomes after kidney transplant.[1][2] One trial is early and safety-focused, while the other is later and compares prevention strategies for CMV.[1][2] In the available data, Valganciclovir Hydrochloride appears in the kidney transplant infection-prevention setting and as part of transplant treatment background in the cell-therapy safety study.[1][2]

Trial ID Phase Condition studied Status Enrollment
2025-520742-29-00 Phase 3 Low-risk renal transplant patients Authorised 170
2024-514398-23-00 Phase 1 Solid organ transplantation (Kidney) Authorised 27

FAQ

  • What are the Valganciclovir Hydrochloride trials studying? They are studying Valganciclovir Hydrochloride in kidney transplant settings, mainly to prevent CMV infection and to support transplant care. One trial also includes it as part of the background treatment in a study of regulatory T cells.
  • Who can take part in these trials? The trials focus on kidney transplant patients. One study is for low-risk renal transplant patients, and another is for deceased donor kidney transplant recipients.
  • What phases are the trials in? The available trials are in Phase 1 and Phase 3. Phase 1 studies usually focus on safety, while Phase 3 studies compare how well treatments work and how safe they are in larger groups.
  • What outcomes are being measured? The trials measure CMV disease, neutropenia, and transplant rejection. The Phase 1 study also measures safety problems such as acute toxicity, infections, and chronic toxicity.
  • Is Valganciclovir Hydrochloride being studied alone? No. In the trial data provided, it is studied as part of kidney transplant care and compared with another antiviral approach in one study. It is also listed among the background medicines in the Treg02 transplant study.

Ongoing Clinical Trials on Valganciclovir Hydrochloride

  • Safety Study of Regulatory T Cells (Treg02) in Patients After Kidney Transplant

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Preventing CMV Infection in Low-Risk Kidney Transplant Patients Using Ganciclovir and Valganciclovir

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Kidney transplant: An operation in which a healthy kidney from a donor is placed into a person whose kidneys no longer work well.
  • Renal transplant: Another term for kidney transplant.
  • Cytomegalovirus (CMV): A common virus that can cause illness after transplant, especially when the immune system is weakened.
  • CMV disease: Illness caused by CMV infection, not just the virus being present in the body.
  • Preemptive therapy: Treatment started early, before full disease develops, usually based on test results or warning signs.
  • Prophylaxis: Treatment given to help prevent a disease before it starts.
  • Phase 1: An early clinical trial phase that mainly checks safety and tolerability.
  • Phase 3: A later trial phase that compares how well a treatment works and how safe it is in a larger group.
  • Neutropenia: A low level of neutrophils, a type of white blood cell that helps fight infection.
  • Biopsy-confirmed acute rejection: A sudden immune attack on the transplanted kidney that is proven by a tissue sample called a biopsy.
  • Tregs: Regulatory T cells, a type of immune cell being studied in one transplant trial to see if they help the body accept the new kidney.
  • Autologous: Made from the patient’s own cells.

References

  1. https://clinicaltrials.gov/study/2024-514398-23-00
  2. https://clinicaltrials.gov/study/2025-520742-29-00