Kidney Transplantation, Cytomegalovirus InfectionsPhase 4NCT01376804
A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
A Phase 4 study testing valganciclovir [Valcyte] in people with Kidney Transplantation, Cytomegalovirus Infections, run by Hoffmann-La Roche at 25 sites in 9 countries.
Trial summary
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. Read more about this study
- Who is it for?
- Ages 4 months to 16 years
- Conditions the study is for
- Kidney Transplantation, Cytomegalovirus Infections
- What is being tested?
- valganciclovir [Valcyte]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 25 sitesin 9 countries
- Study dates
- 31 Jul 2011to 31 May 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children, 4 months to 16 years of age
- Patient has received a kidney transplant
- At risk of developing cytomegalovirus disease
- Adequate hematological and renal function
- Able to tolerate oral medication
- Negative pregnancy test for females of childbearing potential
Who cannot join
- Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
- Severe uncontrolled diarrhea (more than 5 watery stools per day)
- Liver enzyme elevation of more than five times the upper limit of normal for aspartate aminotransferase [AST (SGOT)] or alanine aminotransferase [ALT (SGPT)]
- Patient requires use of any protocol prohibited concomitant medication
- Previous participation in this clinical study
Trial locations and contacts
25 sites in 9 countries.
25 sites in 9 countries
United States4 sites
University of Florida Pediatric Nephrology
Gainesville, Florida
UCLA Center For Health Sciences; Division of Pediatric Nephrology
Los Angeles, Louisiana, 90095-1752
Mount Sinai Medical Center
New York, New York, 10029-6574
Uni of Utah Health Science Center; Pediatric Nephrology
Salt Lake City, Utah, 84108
Germany4 sites
Klinik und Poliklinik für Kinder- und Jugendmedizin- Köln, Uniklinik Köln
Cologne, 50937
Universitätsklinikum für Kinder und Jugendmedizin Hamburg
Hamburg, 20246
KfH Nierenzentrum für Kinder und Jugendliche an der MHH Hannover
Hanover, 30625
Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg
Heidelberg, 69120
Australia3 sites
Royal Children'S Hospital; Department of Nephrology
Parkville, Victoria, 3052
Mater Childrens Hospital
South Brisbane, Herston, Queensland, 4029
Children'S Hospital At Westmead; Department of Nephrology
Westmead, New South Wales, 2145
France3 sites
CHU de Nantes - Service de pédiatrie
Nantes, 44093
Hôpital Robert Debré; Nephrologie pediatrique
Paris, 75019
Hop Necker Enfants Malades;Nephrologie Pediatrique
Paris, 75743
Mexico3 sites
Centenario Hospital Miguel Hidalgo
Aguascalientes, 20230
Instituto Mexicano de Transplantes
Cuernavaca, 62428
Hospital Infantil de Mexico Federico Gomez
México, 06720
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario La Paz: Nefrologia Pediatrica
Madrid, 28046
Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica
Seville, 41013
United Kingdom3 sites
Birmingham Children's Hospital
Birmingham, B4 6NH
Bristol Royal Hospital For Children
Bristol, BS2 8BJ
Royal Hospital For Sick Children; Dept. of Child Health
Glasgow, G3 8SJ
Brazil1 site
Universidade Federal de Sao Paulo - UNIFESP
São Paulo, São Paulo, 04038-002
Sweden1 site
Sahlgrenska Sjukhuset; Transplantationskirurgiska Kliniken
Gothenburg, 41345
About this study
Official title: Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.
- Being tested
- valganciclovir [Valcyte]
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valganciclovir [Valcyte]Drug
Oral, daily for up to 200 days.
| Study group | Role | What they receive |
|---|---|---|
| Valganciclovir | Experimental | Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in milligrams) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance]. Receives: Drug: valganciclovir [Valcyte] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs.
A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
Measured: 52 weeks
Secondary outcomes (7)
Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator
A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia (presence of CMV in the blood) by each study center as part of the clinical assessment required for diagnosis of CMV infection.
Measured: 52 weeks
Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator
A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia by each study center as part of the clinical assessment required for diagnosis of CMV infection. CMV disease included CMV syndrome or tissue invasive CMV. CMV syndrome required fever ≥ 38 degrees Celsius, severe malaise, leukopenia on 2 separate measurements, atypical lymphocytosis ≥ 5%, thrombocytopenia, elevation of hepatic transaminases and presence of CMV in blood. Tissue Invasive CMV required evidence of localized CMV infection in a biopsy or other appropriate symptom and relevant symptoms or signs of organ dysfunction.
Measured: 52 weeks
Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant
Blood samples were sent to a central lab for the quantitative assessment of CMV viral load (amount of CMV in the blood) by an FDA-approved molecular-based assay. The number of participants in each category is reported in copies/milliliter (CP/mL). CMV DNA is detected in all categories < 150 CP/mL and above.
Measured: 52 weeks
Number of Participants With Biopsy Proven Rejection
Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.
Measured: 52 Weeks
Number of Participants With Graft Loss
Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.
Measured: 52 Weeks
Number of Participants With Death
Measured: 52 Weeks
Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)
All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study start31 Jul 2011
- Primary completion31 May 2013
- Study completion31 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney Transplantation, Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376804
- Sponsor's protocol ID
- NV25409
- Other IDs
- 2010-022514-47
- Status last verified
- Jun 2017
- First submitted
- 17 Jun 2011
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT01376804
- Acronym / sponsor ID
- NV25409
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2011 (actual)
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 31 May 2013 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Posted 28 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valganciclovir | Experimental | Drug: valganciclovir [Valcyte]Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in milligrams) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance]. |
Who may qualify
- Ages
- 4 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children, 4 months to 16 years of age
- Patient has received a kidney transplant
- At risk of developing cytomegalovirus disease
- Adequate hematological and renal function
- Able to tolerate oral medication
Key exclusion criteria (5 listed)
- Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
- Severe uncontrolled diarrhea (more than 5 watery stools per day)
- Liver enzyme elevation of more than five times the upper limit of normal for aspartate aminotransferase [AST (SGOT)] or alanine aminotransferase [ALT (SGPT)]
- Patient requires use of any protocol prohibited concomitant medication
- Previous participation in this clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valganciclovir [Valcyte]Oral, daily for up to 200 days. | Drug | Valganciclovir |
Primary outcome
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs
Time frame: 52 weeks
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
7 secondary outcomes
Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator
Time frame: 52 weeks
Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator
Time frame: 52 weeks
Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant
Time frame: 52 weeks
Number of Participants With Biopsy Proven Rejection
Time frame: 52 Weeks
Number of Participants With Graft Loss
Time frame: 52 Weeks
Number of Participants With Death
Time frame: 52 Weeks
Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)
Time frame: 52 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
25 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valganciclovir [Valcyte] in people with Kidney Transplantation, Cytomegalovirus Infections, run by Hoffmann-La Roche at 25 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Germany, Australia, France, Mexico and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.