Kidney TrasplantPhase 4NCT00034385
Valganciclovir to Prevent Cytomegalovirus Infection in Kidney and Kidney/Pancreas Transplant Recipients
A Phase 4 study testing Valganciclovir in people with Kidney Trasplant, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will compare different ways of giving the drugs ganciclovir and valganciclovir to kidney or kidney and pancreas transplant recipients to determine the most effective dose of valganciclovir for protecting against cytomegalovirus (CMV) infection in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Trasplant
- What is being tested?
- Valganciclovir
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2002to 30 Oct 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates receiving kidney or kidney/pancreas transplants at the Warren G. Magnuson Clinical Center who require CMV prophylaxis.
- Willingness and legal ability to give informed consent.
- Estimated creatinine clearance (using MDRD 4 variable equation (16)) of greater than or equal to 60ml/min/1.73m(2) or a 24 hour urine creatinine clearance of greater than or equal to 60ml/min/1.73m(2).
Who cannot join
- Age less than 18 years old.
- Pregnant (pregnancy test as part of transplant protocol).
- Absolute neutrophil count less than 500/mm(3).
- Platelet count less than 50,000/mm(3).
- Severe anemia postoperatively, Hgb less than 8.0 mg/dl despite erythropoetin therapy (subjects can be started on erythropoetin and iron supplementation post transplant).
- Hypersensitivity to ganciclovir or valganciclovir.
- The presence of persistent diarrhea (greater than or equal to 7 stools or stool volume greater than 1 liter per day for greater than or equal to 3 days).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Pharmacokinetics of Valganciclovir in Kidney and Kidney/Pancreas Transplant Recipients
This study will compare different ways of giving the drugs ganciclovir and valganciclovir to kidney or kidney and pancreas transplant recipients to determine the most effective dose of valganciclovir for protecting against cytomegalovirus (CMV) infection in these patients. One of the most common viral infections following organ transplant, CMV can cause serious illness and even death.
Ganciclovir reduces the incidence of CMV disease after kidney transplantation. The drug is given either intravenously (through a vein) twice a day or by mouth 3 times a day. Valganciclovir is converted to ganciclovir in the body and is absorbed into the bloodstream better than oral ganciclovir. In most transplant patients, a single daily dose of valganciclovir prevents CMV. Because of these advantages, some transplant patients are being given valganciclovir instead of ganciclovir to prevent CMV infection. However, the drug has not been studied in kidney and kidney transplant patients. This study will provide dosing information for this patient population.
Read more
Patients 18 years of age and older who have had a kidney or kidney and pancreas transplant at the NIH Clinical Center may be eligible for this study. Participants will undergo the following treatments and procedures:
- Phase 1 - Treatment with intravenous ganciclovir for at least 7 days after transplantation.
Sometime before starting phase 2, patients will provide a 24-hour urine collection to test for kidney function. The day before starting phase 2, they will have a cannula (small needle) inserted into an arm vein for about 12 hours to draw blood samples-one before starting the ganciclovir infusion, then at 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 12 hours after the dose.
- Phase 2 - Treatment with oral valganciclovir once a day for 7 to 21 days at a dose approximately equivalent to intravenous ganciclovir. Sometime between 4 and 21 days on this dose, patients will have blood sampling in the morning before taking the drug and then at 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours after the dose.
- Phase 3 - Treatment with valganciclovir at a dose reduced by half to approximate oral ganciclovir dosing.
After at least 4 days on this dose, patients will be admitted to the hospital for 1 day for blood sampling before the drug dose and then at 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours after the dose. Kidney function will be assessed by blood tests within 2 days of the blood sampling. If kidney function is not within the normal range, further dosing and blood sampling will be delayed until kidney function returns to the normal range.
- Phase 4 - Treatment with oral ganciclovir every 8 hours. After at least 4 days on this regimen, patients will be admitted to the hospital for 1 day for blood sampling before the drug dose and then at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after the dose. Kidney function will be estimated by blood tests within 2 days of the blood sampling. If kidney function is not within the normal range, further dosing and blood sampling will be delayed until kidney function returns to normal range.
After completing phase 4, patients will continue valganciclovir daily or oral ganciclovir treatment and blood sampling for a length of time prescribed by the transplant surgeon.
Read the detailed description
Cytomegalovirus in solid organ transplant recipients can result in significant morbidity and mortality due to concurrent immunosuppression. Traditionally intravenous followed by oral ganciclovir has been used to prevent and treat cytomegalovirus infection and disease in transplant recipients. Recently a new oral form of ganciclovir, valganciclovir has been approved by the Food and Drug Administration for the treatment of CMV retinitis in patients with AIDS. Valganciclovir is more bioavailable and requires fewer daily doses and lower pill burden than oral ganciclovir. In addition valganciclovir can attain ganciclovir plasma levels similar to intravenous ganciclovir. This protocol will test the ability of valganciclovir to provide similar drug exposure (area under the curve, AUC) as oral and intravenous ganciclovir at equivalent doses in the setting of kidney and kidney-pancreas transplantation. Patients will receive four different dosing/dosage form schemes. Intravenous ganciclovir at 2.5mg/kg every 12 hours, which is the usual treatment at this facility post surgery will be administered for approximately 7 days (phase I), then patients will receive valganciclovir 900 mg daily for 7 to 21 days (phase II), then patients will receive 450 mg daily for at least 4 days (phase III), and finally, ganciclovir 1000 mg every 8 hours for at least 4 days (phase IV). Serial blood samples will be collected for pharmacokinetic analyses after each change in dose/dosage form (after each phase). After completion of the study, patients will be maintained on valganciclovir 450 mg daily for CMV prophylaxis or oral ganciclovir for a length of time prescribed by the transplant surgeon. By characterizing the pharmacokinetics of valganciclovir in kidney/pancreas transplant patients, it is hoped that appropriate dosing to prevent CMV disease and limit toxicity may be achieved.
- Conditions
- Kidney Trasplant
- Being tested
- Valganciclovir
- Keywords
- Cytomegalovirus, Prophylaxis, Renal Transplant, Valcyte, Kidney Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2002 (estimated)
- Study start24 Apr 2002
- Primary completion30 Jan 2007
- Study completion30 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney TrasplantStudies of the same condition, open and under way.
- 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
- Treatment
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034385
- Sponsor's protocol ID
- 020168
- Other IDs
- 02-CC-0168
- Status last verified
- 20 Aug 2008
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Fishman JA, Rubin RH. Infection in organ-transplant recipients. N Engl J Med. 1998 Jun 11;338(24):1741-51. doi: 10.1056/NEJM199806113382407. No abstract available.
PubMed 9624195Rubin RH. The indirect effects of cytomegalovirus infection on the outcome of organ transplantation. JAMA. 1989 Jun 23-30;261(24):3607-9. No abstract available.
PubMed 2542634Patel R, Snydman DR, Rubin RH, Ho M, Pescovitz M, Martin M, Paya CV. Cytomegalovirus prophylaxis in solid organ transplant recipients. Transplantation. 1996 May 15;61(9):1279-89. doi: 10.1097/00007890-199605150-00001. No abstract available.
PubMed 8629285
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Valganciclovir in Kidney and Kidney/Pancreas Transplant Recipients
- ClinicalTrials.gov ID
- NCT00034385
- Acronym / sponsor ID
- 020168
- Conditions
- Kidney Trasplant
- Keywords
- Cytomegalovirus, Prophylaxis, Renal Transplant, Valcyte, Kidney Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 24 Apr 2002
- Primary completion
- 30 Jan 2007 (actual)
- Study completion
- 30 Oct 2009 (actual)
- First posted
- 29 Apr 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare different ways of giving the drugs ganciclovir and valganciclovir to kidney or kidney and pancreas transplant recipients to determine the most effective dose of valganciclovir for protecting against cytomegalovirus (CMV) infection in these patients. One of the most common viral infections following organ transplant, CMV can cause serious illness and even death.
Ganciclovir reduces the incidence of CMV disease after kidney transplantation. The drug is given either intravenously (through a vein) twice a day or by mouth 3 times a day. Valganciclovir is converted to ganciclovir in the body and is absorbed into the bloodstream better than oral ganciclovir. In most transplant patients, a single daily dose of valganciclovir prevents CMV. Because of these advantages, some transplant patients are being given valganciclovir instead of ganciclovir to prevent CMV infection. However, the drug has not been studied in kidney and kidney transplant patients. This study will provide dosing information for this patient population.
Patients 18 years of age and older who have had a kidney or kidney and pancreas transplant at the NIH Clinical Center may be eligible for this study. Participants will undergo the following treatments and procedures:
- Phase 1 - Treatment with intravenous ganciclovir for at least 7 days after transplantation.
Sometime before starting phase 2, patients will provide a 24-hour urine collection to test for kidney function. The day before starting phase 2, they will have a cannula (small needle) inserted into an arm vein for about 12 hours to draw blood samples-one before starting the ganciclovir infusion, then at 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 12 hours after the dose.
- Phase 2 - Treatment with oral valganciclovir once a day for 7 to 21 days at a dose approximately equivalent to intravenous ganciclovir. Sometime between 4 and 21 days on this dose, patients will have blood sampling in the morning before taking the drug and then at 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours after the dose.
- Phase 3 - Treatment with valganciclovir at a dose reduced by half to approximate oral ganciclovir dosing.
After at least 4 days on this dose, patients will be admitted to the hospital for 1 day for blood sampling before the drug dose and then at 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours after the dose. Kidney function will be assessed by blood tests within 2 days of the blood sampling. If kidney function is not within the normal range, further dosing and blood sampling will be delayed until kidney function returns to the normal range.
- Phase 4 - Treatment with oral ganciclovir every 8 hours. After at least 4 days on this regimen, patients will be admitted to the hospital for 1 day for blood sampling before the drug dose and then at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after the dose. Kidney function will be estimated by blood tests within 2 days of the blood sampling. If kidney function is not within the normal range, further dosing and blood sampling will be delayed until kidney function returns to normal range.
After completing phase 4, patients will continue valganciclovir daily or oral ganciclovir treatment and blood sampling for a length of time prescribed by the transplant surgeon.
Detailed description
Cytomegalovirus in solid organ transplant recipients can result in significant morbidity and mortality due to concurrent immunosuppression. Traditionally intravenous followed by oral ganciclovir has been used to prevent and treat cytomegalovirus infection and disease in transplant recipients. Recently a new oral form of ganciclovir, valganciclovir has been approved by the Food and Drug Administration for the treatment of CMV retinitis in patients with AIDS. Valganciclovir is more bioavailable and requires fewer daily doses and lower pill burden than oral ganciclovir. In addition valganciclovir can attain ganciclovir plasma levels similar to intravenous ganciclovir. This protocol will test the ability of valganciclovir to provide similar drug exposure (area under the curve, AUC) as oral and intravenous ganciclovir at equivalent doses in the setting of kidney and kidney-pancreas transplantation. Patients will receive four different dosing/dosage form schemes. Intravenous ganciclovir at 2.5mg/kg every 12 hours, which is the usual treatment at this facility post surgery will be administered for approximately 7 days (phase I), then patients will receive valganciclovir 900 mg daily for 7 to 21 days (phase II), then patients will receive 450 mg daily for at least 4 days (phase III), and finally, ganciclovir 1000 mg every 8 hours for at least 4 days (phase IV). Serial blood samples will be collected for pharmacokinetic analyses after each change in dose/dosage form (after each phase). After completion of the study, patients will be maintained on valganciclovir 450 mg daily for CMV prophylaxis or oral ganciclovir for a length of time prescribed by the transplant surgeon. By characterizing the pharmacokinetics of valganciclovir in kidney/pancreas transplant patients, it is hoped that appropriate dosing to prevent CMV disease and limit toxicity may be achieved.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Candidates receiving kidney or kidney/pancreas transplants at the Warren G. Magnuson Clinical Center who require CMV prophylaxis.
- Willingness and legal ability to give informed consent.
- Estimated creatinine clearance (using MDRD 4 variable equation (16)) of greater than or equal to 60ml/min/1.73m(2) or a 24 hour urine creatinine clearance of greater than or equal to 60ml/min/1.73m(2).
Key exclusion criteria (7 listed)
- Age less than 18 years old.
- Pregnant (pregnancy test as part of transplant protocol).
- Absolute neutrophil count less than 500/mm(3).
- Platelet count less than 50,000/mm(3).
- Severe anemia postoperatively, Hgb less than 8.0 mg/dl despite erythropoetin therapy (subjects can be started on erythropoetin and iron supplementation post transplant).
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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 9624195Fishman JA, Rubin RH. Infection in organ-transplant recipients. N Engl J Med. 1998 Jun 11;338(24):1741-51. doi: 10.1056/NEJM199806113382407. No abstract available.
- Background: PubMed 2542634Rubin RH. The indirect effects of cytomegalovirus infection on the outcome of organ transplantation. JAMA. 1989 Jun 23-30;261(24):3607-9. No abstract available.
- Background: PubMed 8629285Patel R, Snydman DR, Rubin RH, Ho M, Pescovitz M, Martin M, Paya CV. Cytomegalovirus prophylaxis in solid organ transplant recipients. Transplantation. 1996 May 15;61(9):1279-89. doi: 10.1097/00007890-199605150-00001. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valganciclovir in people with Kidney Trasplant, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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 3 inclusion and 7 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 2 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 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00034385, 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 2 Jul 2017.