Cytomegalovirus InfectionsPhase 3IMPACTNCT00294515

IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients

A Phase 3 study testing Valganciclovir in people with Cytomegalovirus Infections, run by Hoffmann-La Roche at 80 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Cytomegalovirus Infections
What is being tested?: Valganciclovir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 326 participants
Where: 80 sitesin 13 countries
Study dates: 31 Mar 2006to 31 Aug 2009
Phase: Phase 3
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

≥ 16 years of age
CMV seronegative recipient of primary or secondary renal allograft from a living or cadaveric seropositive donor
Adequate hematological and renal function
Patients and partners must agree to maintain effective birth control for 90 days following cessation of study medication

Who cannot join

CMV disease, or receipt of anti-CMV therapy within 30 days prior to screening
Multi-organ transplant recipient
Hepatitis B, hepatitis C or HIV positive
Women who are pregnant or lactating

Trial locations and contacts

80 sites in 13 countries.

Country

City, postcode or hospital

80 sites in 13 countries

United States23 sites

Uni of Michigan Medical Center
Ann Arbor, Michigan, 48109-0331
Uni of Alabama At Birmingham
Birmingham, Alabama, 35294
New England Medical Center; Division of Transplant Surgery
Boston, Massachusetts, 02111
Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program
Chicago, Illinois, 60612-3824
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Indiana Uni Medical Center; Surgery & Microbiology/Immunology
Indianapolis, Indiana, 46202-5124
St. Barnabas Medical Center
Livingston, New Jersey, 07039
National Institute of Transplantation
Los Angeles, California, 90057
UCLA Medical Center
Los Angeles, California, 90095
Uni of Minnesota Medical Center; Dept of Surgery
Minneapolis, Minnesota, 55455
Vanderbilt Uni ; Divison of Nephrology
Nashville, Tennessee, 37232
Robert Wood Johnson Uni Hospital; Anesthesia
New Brunswick, New Jersey, 08901
Hahnemann Uni Hospital; Division of Transplant/Dept. of Surgery
Philadelphia, Pennsylvania, 19102-1192
Uni of Pennslyvania Medical Center
Philadelphia, Pennsylvania, 19104
Oregon Health Sciences Uni ; Division of Nephrology
Portland, Oregon, 97201
Texas Transplant Inst.
San Antonio, Texas, 78229
Uni of Texas Health Science Center At San Antonio; Organ Transplant Program
San Antonio, Texas, 78284
Ucsd Medical Center; Kidney Transplantation
San Diego, California, 92103-8401
California Pacific Medical Center
San Francisco, California, 94115
Uni of California San Francisco; Transplant Services
San Francisco, California, 94143-0116
Uni of Washington Medical Center; Division of Allergy & Infectious Diseases
Seattle, Washington, 98195
Lifelink Healthcare Inst.
Tampa, Florida, 33606
Wake Forest Uni School of Medicine; Section on Infectious Diseases
Winston-Salem, North Carolina, 27157-1082

Other trials in United States

United Kingdom10 sites

Antrim Hospital; Renal Dept
Antrim, 2RL
Queen Elizabeth Hospital
Birmingham, B15 2TH
SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre
Bristol, BS10 5NB
Western Infirmary; Division of Cardiovascular and Medical Sciences
Glasgow, G11 6NT
Royal Liverpool Uni Hospital; Renal Dept
Liverpool, L7 8XP
Royal London Hospital; Renal Unit
London, E1 1BB
Manchester Royal Infirmary; Renal Transplant Unit
Manchester, M13 9WL
Freeman Hospital; Nephrology
Newcastle upon Tyne, NE7 7DN
Nottingham City Hospital; Transplant Unit
Nottingham, NG5 1PB
Churchill Hospital; Oxford Transplant Center Renal Transplant Unit
Oxford, OX3 7LJ

Other trials in United Kingdom

France9 sites

Hopital Pellegrin; Departement Nephrologie
Bordeaux, 33076
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
Grenoble, 38043
Hopital Lapeyronie; Nephrologie
Montpellier, 34295
Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique
Nantes, 44035
Ch Pitie Salpetriere; Urologie
Paris, 75651
Hopital Civil; Clinique Medicale
Strasbourg, 67091
CHU de Toulouse, Hopital Rangueil; Nephrologie-Tranplantation
Toulouse, 31403
Hopital Bretonneau; Nephrologie Transplantations
Tours, 37044
Hopitaux De Brabois; Nephrologie
Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany7 sites

Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie
Berlin, 10117
Charite - Campus, Virchow-Klinikum; Abteilung Fuer Nephrologie Und Intensivmedizin
Berlin, 13353
Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie
Erlangen, 91054
Klinik Johann Wolfgang von Goethe Uni; Innere Medizin - Dialyse
Frankfurt, 60596
Med. Hochschule Hannover Zentrum Chirurgie Klinik f.Allgemein- Viszeral- und Transplantationschirur
Hanover, 30625
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Medizinische Klinik I
Lübeck, 23562
Klinikum der Universitaet Regensburg; Nephrologie
Regensburg, 93053

Other trials in Germany

Spain6 sites

Hospital de Cruces; Servicio de Enfermedades Infecciosas
Barakaldo, Vizcaya, 48903
Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
Barcelona, 08035
Hospital Universitari de Bellvitge; Servicio de Nefrologia
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital General Univ. Gregorio Maranon
Madrid, 28009
Hospital Universitario 12 de Octubre; Servicio de Enfermedades Infecciosas
Madrid, 28041
Hospital Universitario Dr. Peset; Servicio de Nefrologia
Valencia, 46017

Other trials in Spain

Brazil5 sites

Hospital das Clinicas - UNICAMP
Campinas, São Paulo, 13083-888
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-003
Hospital Israelita Albert Einstein; Intensive Care Unit
São Paulo, São Paulo, 05651-901
Faculdade de Medicina de Ribeirao Preto Usp; Campus Uni Rio
São Paulo, São Paulo, 18048-900

Other trials in Brazil

Canada4 sites

Uni of Alberta Hospital
Edmonton, Alberta, T6G 2S2
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, H3A 1A1
Toronto General Hospital
Toronto, Ontario, M5G 2N2

Other trials in Canada

Italy4 sites

Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
Bari, Apulia, 70124
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi
Milan, Lombardy, 20162
Azienda Ospedaliera DI PADOVA; Divisione Malattie Infettive
Padova, Veneto, 35128
POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo
Rome, Lazio, 00168

Other trials in Italy

Australia3 sites

Royal Prince Alfred Hospital; Renal Transplant Unit
Camperdown, New South Wales, 2050
Monash Medical Centre; Renal Transplant Unit
Clayton, Victoria, 3186
Royal Melbourne Hospital; Nephrology
Parkville, Victoria, 3050

Other trials in Australia

Belgium3 sites

Clin Univ de Bxl Hôpital Erasme
Brussels, 1070
UZ Gent
Ghent, 9000
UZ Leuven Gasthuisberg
Leuven, 3000

Other trials in Belgium

Poland3 sites

Collegium Medicum Uniwersytetu Jagielonskiego; Katedra I Klinika Nefrologii Cmuj
Krakow, 31-501
Instytut Transplantologii A.M.; Klinika Medycyny Transplantacyjnej I Nefrologii
Warsaw, 02-006
Akademia Medyczna Im. Piastow Slaskich; Klinika Nefrologii I Medycyny Transplantacyjnej
Wroclaw, 50-417

Other trials in Poland

Romania2 sites

Institutul de Urologie Si Transplant Renal Fundeni
Bucharest, 022328
Institutul de Urologie Si Transplant Renal Cluj Napoca
Cluj-Napoca, 400006

Other trials in Romania

New Zealand1 site

Auckland City Hospital; Renal Unit, Level 15
Auckland, 1001

Other trials in New Zealand

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Efficacy and Safety of up to 100 Days of Valganciclovir Versus up to 200 Days of Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Kidney Allograft Recipients

Conditions: Cytomegalovirus Infections
Being tested: Valganciclovir
Medical subject headings: Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ValganciclovirDrug
Also called Valcyte
900 mg orally daily for up to 100 days
ValganciclovirDrug
Also called Valcyte
900 mg orally daily for up to 200 days

Study groups in NCT00294515
Study group	Role	What they receive
Valganciclovir up to 100 days	Experimental	Valganciclovir for up to 100 days post kidney transplant Receives: Drug: Valganciclovir
Valganciclovir up to 200 days	Active comparator	Valganciclovir for up to 200 days post kidney transplant Receives: Drug: Valganciclovir

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant
Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.
Measured: 12 months post-transplant

Secondary outcomes (4)

Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant
Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 6 months post-transplant.
Measured: 6 months post-transplant
Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant
Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 9 months post-transplant.
Measured: 9 months post-transplant
Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant
Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 18 months post-transplant.
Measured: 18 months post-transplant
Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant
Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 24 months post-transplant.
Measured: 24 months post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 200631 Aug 2009

First posted22 Feb 2006 (estimated)
Study start31 Mar 2006
Primary completion31 Aug 2008
Study completion31 Aug 2009

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 326 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00294515
Sponsor's protocol ID: NT18435
Acronym: IMPACT
Status last verified: Feb 2018
First submitted: 21 Feb 2006
Last updated: 29 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.
PubMed 39807668
Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.
PubMed 38700045
Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.
PubMed 20353469

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

All Cytomegalovirus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Efficacy and Safety of up to 100 Days of Valganciclovir Versus up to 200 Days of Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Kidney Allograft Recipients
ClinicalTrials.gov ID: NCT00294515
Acronym / sponsor ID: IMPACT / NT18435
Conditions: Cytomegalovirus Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 326 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 31 Mar 2006 (actual)
Primary completion: 31 Aug 2008 (actual)
Study completion: 31 Aug 2009 (actual)
First posted: 22 Feb 2006 (estimated)
Results: Posted 5 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Valganciclovir up to 100 days	Experimental	Drug: ValganciclovirValganciclovir for up to 100 days post kidney transplant
Valganciclovir up to 200 days	Active comparator	Drug: ValganciclovirValganciclovir for up to 200 days post kidney transplant

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

≥ 16 years of age
CMV seronegative recipient of primary or secondary renal allograft from a living or cadaveric seropositive donor
Adequate hematological and renal function
Patients and partners must agree to maintain effective birth control for 90 days following cessation of study medication

Key exclusion criteria (4 listed)

CMV disease, or receipt of anti-CMV therapy within 30 days prior to screening
Multi-organ transplant recipient
Hepatitis B, hepatitis C or HIV positive
Women who are pregnant or lactating

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
ValganciclovirAlso: Valcyte900 mg orally daily for up to 100 days	Drug	Valganciclovir up to 100 days
ValganciclovirAlso: Valcyte900 mg orally daily for up to 200 days	Drug	Valganciclovir up to 200 days

Primary outcome

Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant
Time frame: 12 months post-transplant
Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.

4 secondary outcomes

Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant
Time frame: 6 months post-transplant
Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant
Time frame: 9 months post-transplant
Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant
Time frame: 18 months post-transplant
Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant
Time frame: 24 months post-transplant

Results and safety

Results posted to the registry on 5 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Valganciclovir up to 100 Days	166	132
Valganciclovir up to 200 Days	160	132

Primary outcome: Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant

Time frame: 12 months post-transplant. Mean (95% Confidence Interval). Unit: Percentage of patients

Measure	Valganciclovir up to 100 Days n = 163	Valganciclovir up to 200 Days n = 155
Value	43.6 (35.8 to 51.5)	23.9 (17.4 to 31.4)

Valganciclovir up to 100 Days vs Valganciclovir up to 200 Days: Odds Ratio (OR): 0.40 (95% CI 0.25 to 0.66), p <=0.0002, Cochran-Mantel-Haenszel

Population analysed: Intent-to-treat population

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Valganciclovir up to 100 Days	94 of 164 (57.3%)	133 of 164 (81.1%)	Not reported
Valganciclovir up to 200 Days	78 of 156 (50%)	141 of 156 (90.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39807668Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.
Derived from this study: PubMed 38700045Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.
Derived from this study: PubMed 20353469Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.

Related trials for Cytomegalovirus Infections

RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

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 chair

Hoffmann-La Roche

80 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Valganciclovir in people with Cytomegalovirus Infections, run by Hoffmann-La Roche at 80 sites in 13 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 4 inclusion and 4 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, United Kingdom, France, Germany, Spain and 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 Jul 2010). 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?

Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant (time frame: 12 months post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00294515, which also lists 3 linked publications.

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 29 Mar 2018.