Kidney TransplantationPhase 3NCT00000936
A Study To Test An Anti-Rejection Therapy After Kidney Transplantation
A Phase 3 study testing hOKT3, Oral Cyclosporine and IV Cyclosporine in people with Kidney Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- hOKT3, Oral Cyclosporine and IV Cyclosporine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to Mar 2004
- Phase
- Phase 3
- 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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and young adults may be eligible for this study if they:
- Are not yet 21 years of age.
- Are receiving their first or second transplant.
- Are not pregnant.
- Agree to practice sexual abstinence or agree to use an effective
- method of birth control/contraception during the study and
- for 1 year after.
Who cannot join
- Children and young adults will not be eligible for this study if they:
- Are recipients of multiple organs other than kidneys.
- Are recipients of three or more transplants.
- Are HIV positive.
- Are Hepatitis B surface antigen positive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Trial of Induction Therapy in Renal Transplantation
Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective.
Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.
Read the detailed description
Renal transplantation is recognized as the treatment of choice for children with chronic renal failure. However, patient and graft survival rates in young children are unacceptably low. In preliminary studies, OKT3 (a monoclonal antibody) induction therapy received post transplant has been more successful than standard immunosuppression alone in improving graft survival. This study is designed to assess the impact of induction therapy on graft survival in pediatric kidney transplant patients.
Patients are assigned to OKT3 induction or no induction in a 1:1 ratio. Randomization to oral cyclosporine of either Sandimmune or Neoral is also done in a 1:1 ratio. Group 1 receives OKT3 intraoperatively followed by Neoral. Group 2 receives OKT3 intraoperatively followed by Sandimmune. OKT3 is administered at 2.5 mg (if weight less than 30 kg) or 5 mg (if weight above 30 kg) per day for a maximum of 14 days. Group 3 receives IV cyclosporine followed by Neoral. Group 4 receives IV cyclosporine followed by Sandimmune. Oral cyclosporine is administered in a masked preparation. The dose for Sandimmune and Neoral is the same; patients 6 years of age and older begin at a dose of 15 mg/kg/day and patients under 6 years of age receive 500 mg/m2/day. Patients will receive concomitant medications including steroids (IV and po), Nifedipine, anti-CMV therapy, Bactrim, Azathioprine or Mycophenolate Mofetil. Kidney function, incidence of viral infection, graft survival, and incidence of malignancy will be measured to assess the role of OKT3 induction and the role of rejection in graft failure. Graft function will be evaluated at 1-, 2-, and 4-year intervals.
- Conditions
- Kidney Transplantation
- Being tested
- hOKT3, Oral Cyclosporine, IV Cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hOKT3Drug
Administered both during and after transplantation in IV form. Dosage determined by individual weight and given for a maximum of 14 days.
Oral CyclosporineDrug
Administered orally as either sandimmune or neoral at a dose determined by weight. Patients 6 years of age and older begin at a dose of 15 mg/kg/day and patients under 6 years of age receive 500 mg/m2/day, for the duration of the study.
IV CyclosporineDrug
Administered intravenously (IV) both during and after transplantation at a dosage determined by individual age.
| Study group | Role | What they receive |
|---|---|---|
| Induction | Experimental | subjects receiving hOKT3 induction therapy Receives: Drug: hOKT3; Drug: Oral Cyclosporine |
| Induction Free Therapy | Active comparator | Patients not receiving induction therapy Receives: Drug: Oral Cyclosporine; Drug: IV Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine one-year graft function, as measured by graft survival and serum creatinine of children undergoing OKT3 induction versus no induction
Measured: At 1 year
To compare the efficacy of Sandimmune and Neoral with respect to graft function
Measured: Throughout study
Secondary outcomes (8)
Two and four-year graft functions
Measured: At 2 and 4 years
Safety with respect to viral infections and malignancies in children undergoing a renal transplant
Measured: Throughout study
Frequency and severity of rejection episodes
Measured: Throughout study
Time to first rejection
Measured: Throughout study
Length and frequency of hospitalization
Measured: Throughout study
Nature of acute cellular rejection at a molecular level
Measured: Throughout study
Nature of "heightened immune response" of younger children by studying gene expression in surveillance biopsies
Measured: Throughout study
Correlate intragraft events during rejection with cytokine profile in the peripheral blood
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startNov 1999
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- 292 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000936
- Sponsor's protocol ID
- DAIT IN01/OLN-359
- Status last verified
- Jan 2017
- First submitted
- 2 Nov 1999
- Last updated
- 11 Jan 2017
- Results posted
- No
- Individual data sharing
- Yes: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial of Induction Therapy in Renal Transplantation
- ClinicalTrials.gov ID
- NCT00000936
- Acronym / sponsor ID
- DAIT IN01/OLN-359
- Conditions
- Kidney Transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 292 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 1999
- Study completion
- Mar 2004 (actual)
- First posted
- 31 Aug 2001 (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.
Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective.
Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.
Detailed description
Renal transplantation is recognized as the treatment of choice for children with chronic renal failure. However, patient and graft survival rates in young children are unacceptably low. In preliminary studies, OKT3 (a monoclonal antibody) induction therapy received post transplant has been more successful than standard immunosuppression alone in improving graft survival. This study is designed to assess the impact of induction therapy on graft survival in pediatric kidney transplant patients.
Patients are assigned to OKT3 induction or no induction in a 1:1 ratio. Randomization to oral cyclosporine of either Sandimmune or Neoral is also done in a 1:1 ratio. Group 1 receives OKT3 intraoperatively followed by Neoral. Group 2 receives OKT3 intraoperatively followed by Sandimmune. OKT3 is administered at 2.5 mg (if weight less than 30 kg) or 5 mg (if weight above 30 kg) per day for a maximum of 14 days. Group 3 receives IV cyclosporine followed by Neoral. Group 4 receives IV cyclosporine followed by Sandimmune. Oral cyclosporine is administered in a masked preparation. The dose for Sandimmune and Neoral is the same; patients 6 years of age and older begin at a dose of 15 mg/kg/day and patients under 6 years of age receive 500 mg/m2/day. Patients will receive concomitant medications including steroids (IV and po), Nifedipine, anti-CMV therapy, Bactrim, Azathioprine or Mycophenolate Mofetil. Kidney function, incidence of viral infection, graft survival, and incidence of malignancy will be measured to assess the role of OKT3 induction and the role of rejection in graft failure. Graft function will be evaluated at 1-, 2-, and 4-year intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction | Experimental | Drug: hOKT3, Drug: Oral Cyclosporinesubjects receiving hOKT3 induction therapy |
| Induction Free Therapy | Active comparator | Drug: Oral Cyclosporine, Drug: IV CyclosporinePatients not receiving induction therapy |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Are not yet 21 years of age.
- Are receiving their first or second transplant.
- Are not pregnant.
- Agree to practice sexual abstinence or agree to use an effective
- method of birth control/contraception during the study and
Key exclusion criteria (5 listed)
- Are recipients of multiple organs other than kidneys.
- Are recipients of three or more transplants.
- Are HIV positive.
- Are Hepatitis B surface antigen positive.
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 |
|---|---|---|
| hOKT3Administered both during and after transplantation in IV form. Dosage determined by individual weight and given for a maximum of 14 days. | Drug | Induction |
| Oral CyclosporineAdministered orally as either sandimmune or neoral at a dose determined by weight. Patients 6 years of age and older begin at a dose of 15 mg/kg/day and patients under 6 years of age receive 500 mg/m2/day, for the duration of the study. | Drug | Induction, Induction Free Therapy |
| IV CyclosporineAdministered intravenously (IV) both during and after transplantation at a dosage determined by individual age. | Drug | Induction Free Therapy |
Primary outcome
To determine one-year graft function, as measured by graft survival and serum creatinine of children undergoing OKT3 induction versus no induction
Time frame: At 1 year
To compare the efficacy of Sandimmune and Neoral with respect to graft function
Time frame: Throughout study
8 secondary outcomes
Two and four-year graft functions
Time frame: At 2 and 4 years
Safety with respect to viral infections and malignancies in children undergoing a renal transplant
Time frame: Throughout study
Frequency and severity of rejection episodes
Time frame: Throughout study
Time to first rejection
Time frame: Throughout study
Length and frequency of hospitalization
Time frame: Throughout study
Nature of acute cellular rejection at a molecular level
Time frame: Throughout study
Nature of "heightened immune response" of younger children by studying gene expression in surveillance biopsies
Time frame: Throughout study
Correlate intragraft events during rejection with cytokine profile in the peripheral blood
Time frame: Throughout study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- The National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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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 3 study testing hOKT3, Oral Cyclosporine and IV Cyclosporine in people with Kidney Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 7 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: stopped early, as of the sponsor's last update on 11 Jan 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 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?
The study was stopped early. Results are not available in the source record.
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?
To determine one-year graft function, as measured by graft survival and serum creatinine of children undergoing OKT3 induction versus no induction (time frame: At 1 year). The study lists 2 primary outcomes in all. 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 Jan 2017.