Kidney TransplantSTNNCT01126333
Long-term Follow-up of Spare the Nephron (STN) Patients
An observational study of Kidney Transplant, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Allograft nephropathy is the most common cause of allograft failure following kidney transplantation. Among putative etiologies, cumulative exposure to calcineurin inhibitors may be one of the important progression factors. "Spare the Nephron"(STN) is a unique study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to 30 Jun 2015
- Phase
- Observational
- 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
Study population: Kidney transplant recipients who were previously enrolled in the Spare-the-nephron study.
Who may be able to join
- Male or female post-transplant patients who were in the Spare-the-nephron study.
- Patients capable of understanding the purpose and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
- Women of child bearing potential must not be pregnant or breast-feeding.
- Women of child bearing age must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy or hysterectomy. Effective contraception must be used before beginning of study drug therapy, for duration of study and for 12 weeks following the completion of study.
- Must pass the evaluation to sign informed consent form.
Who cannot join
- Male or female post-transplant patients who were enrolled in the Spare-the-nephron study, however dropped out during the study period.
- Inability to pass the Evaluation to Sign Consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medicine, Division of Adult Nephrology
Baltimore, Maryland, 21201
About this study
Official title: Long-term Follow-up of Sirolimus-based Therapy Versus Continued Tacrolimus-based Therapy in Renal Allograft Recipients.
Allograft nephropathy is the most common cause of allograft failure following kidney transplantation. Among putative etiologies, cumulative exposure to calcineurin inhibitors may be one of the important progression factors.
"Spare the Nephron"(STN) is a unique study. Patients were randomized to either continue center-specific Calcinerium Inhibitor (CNI) therapy or have CNI replaced with sirolimus within the first six months after transplantation. Approximately 305 patients were enrolled in the study. More than 230 patients finished 2 years of follow-up. There was better patient and graft survival in those converted to sirolimus. There was also a 10% improvement in the kidney function of those who were converted. In this cohort, we wish to explore the durability of this improvement.
Read the detailed description
In this extension study we will be extending our clinical observation of the STN patients from two to five years. It is expected that a Calcinerium Inhibitor (CNI) sparing regimen will be associated with better preservation of kidney function and fewer cardiovascular events.
STN is a prospective multi-center study that has completed enrollment of 305 first time recipients of kidney allografts from 27 centers. The enrollees were randomly assigned either to continue the center-specific CNI regimen (assigned at the time of transplantation) or were switched to replace the CNI with sirolimus therapy. Either CNI or sirolimus are being used in combination with CellCept therapy with or without the use of maintenance steroids, based on individual center preferences. Induction therapy was also center-specific.
In the present long-term follow-up study we will approach patients previously enrolled in the STN study and offer them the opportunity to enroll to be followed for another 3 years. There will be no changes in immunosuppression unless clinically indicated. The majority of the effort is standard care with every 6 month follow-up appointments.They will be required to be consented to participate in the three year extension study.
Research procedures:
The only inclusion criteria is willingness to sign the consent form for the extension study, after successful completion of the two year STN study.
Study entry is defined as the point at which they sign the consent form, and agree to participate in the study extension.All patients will be followed for 3 years from their initial screening visit. There will be 7 visits during the study period. All procedures will be standard care for long-term transplant follow-up, with no changes in immunosuppression unless clinically indicated. The only exception to standard of care is obtaining a 24 hour urine for protein and creatinine clearance every 6 months during the follow-up.
Visit 1 (Study entry) 1. Review of inclusion/exclusion criteria 2. Medical history, recipient's age, gender and race 3. Complete transplant information i. date of transplant ii. tissue and ABO typing iii. B-Cell cross match, PRA iv. Patient/donor EBV and CMV serology
The patients will stay on the same immunosuppression as they were receiving in the STN study, unless medications were changed due to medical reasons. They will be routinely monitored as per center practice.
The drugs are given as standard of care and the extension of this study does not alter the participants' medication regimen.
The following laboratory evaluations are typically performed at each visit.
- Tacrolimus / sirolimus trough concentration. Immunosuppressive regimen will be reviewed and changed or adjusted as necessary.
- CBC with differential
- Chemistry panel: glucose, Na, K, Cl, CO2, Ca, P, Mg, blood urea nitrogen (BUN), albumin and total protein, AST, ALT, bilirubin (total), alkaline phosphatase and serum creatinine 4 Estimated GFR from blood and urine data.
- Fasting lipid profile: total cholesterol, LDL, HDL, HDL/LDL ratio, triglycerides
The following clinical assessments will also be performed and recorded in each visit: 1. Vital signs 2. Weight measurements 3. Concomitant medications 4. Adverse events 5. Opportunistic infections 6. Malignancies 7. Clinical evaluation of signs or symptoms of rejection
Number of patients with adverse events will be summarized by body system and each adverse event. Incidence of adverse events will also be summarized by severity and relationship to study medication. Any serious adverse events or deaths will be summarized separately. patient death, graft loss, the need to be withdrawn from the original assigned calcineurin inhibitor therapy patients who return to dialysis for 6 or more consecutive weeks, patients who experience adverse events that lead to premature withdrawal or loss to follow-up. Patients will be followed until the end of the study in all cases. All failed patients will be followed until the end of the last follow up visit (36 months) unless consent is withdrawn. The proportion of patients experiencing any opportunistic infections will be summarized up to 6, 12, 24 ,and 36 months after randomization.
- Conditions
- Kidney Transplant
- Keywords
- Nephrotoxicity, Kidney Transplantation, Graft Survival, Kidney transplant survival.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Long term Sirolimus or Tacrolimus | Ths study cohort will consist of participants who successfully completed two years of the original Spare the Nephron (STN) study, a two year prospective multi-center study where participants were assigned to receive either center-specific CNI regimen (assigned at the time of transplantation) or were switched to replace the CNI with Sirolimus therapy. In this current long-term follow-up study, we will approach patients who previously enrolled in the STN study and offer them the opportunity to enroll to be followed-up for another 3 years. There will be no change in immunosuppression unless clinically indicated. The majority of effort is standard care with every 6 month follow-up appointments.Participants will be required to consent to participate in the three year extension study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare between treatment groups, change in renal function as measured by 24 hour creatinine clearance and estimated GFR.
Measured: Every 6 months for 3 years.
Secondary outcomes (1)
Graft and patient survival.
Measured: Every 6 months for 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startJun 2010
- Primary completion30 Jun 2014
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Matthew R Weir, University of Maryland, Baltimore
- Investigators
- Matthew R Weir, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126333
- Sponsor's protocol ID
- HP-00042739
- Acronym
- STN
- Status last verified
- Apr 2022
- First submitted
- 17 May 2010
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Sirolimus-based Therapy Versus Continued Tacrolimus-based Therapy in Renal Allograft Recipients.
- ClinicalTrials.gov ID
- NCT01126333
- Acronym / sponsor ID
- STN / HP-00042739
- Conditions
- Kidney Transplant
- Keywords
- Nephrotoxicity, Kidney Transplantation, Graft Survival, Kidney transplant survival.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2010
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 19 May 2010 (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.
Allograft nephropathy is the most common cause of allograft failure following kidney transplantation. Among putative etiologies, cumulative exposure to calcineurin inhibitors may be one of the important progression factors.
"Spare the Nephron"(STN) is a unique study. Patients were randomized to either continue center-specific Calcinerium Inhibitor (CNI) therapy or have CNI replaced with sirolimus within the first six months after transplantation. Approximately 305 patients were enrolled in the study. More than 230 patients finished 2 years of follow-up. There was better patient and graft survival in those converted to sirolimus. There was also a 10% improvement in the kidney function of those who were converted. In this cohort, we wish to explore the durability of this improvement.
Detailed description
In this extension study we will be extending our clinical observation of the STN patients from two to five years. It is expected that a Calcinerium Inhibitor (CNI) sparing regimen will be associated with better preservation of kidney function and fewer cardiovascular events.
STN is a prospective multi-center study that has completed enrollment of 305 first time recipients of kidney allografts from 27 centers. The enrollees were randomly assigned either to continue the center-specific CNI regimen (assigned at the time of transplantation) or were switched to replace the CNI with sirolimus therapy. Either CNI or sirolimus are being used in combination with CellCept therapy with or without the use of maintenance steroids, based on individual center preferences. Induction therapy was also center-specific.
In the present long-term follow-up study we will approach patients previously enrolled in the STN study and offer them the opportunity to enroll to be followed for another 3 years. There will be no changes in immunosuppression unless clinically indicated. The majority of the effort is standard care with every 6 month follow-up appointments.They will be required to be consented to participate in the three year extension study.
Research procedures:
The only inclusion criteria is willingness to sign the consent form for the extension study, after successful completion of the two year STN study.
Study entry is defined as the point at which they sign the consent form, and agree to participate in the study extension.All patients will be followed for 3 years from their initial screening visit. There will be 7 visits during the study period. All procedures will be standard care for long-term transplant follow-up, with no changes in immunosuppression unless clinically indicated. The only exception to standard of care is obtaining a 24 hour urine for protein and creatinine clearance every 6 months during the follow-up.
Visit 1 (Study entry) 1. Review of inclusion/exclusion criteria 2. Medical history, recipient's age, gender and race 3. Complete transplant information i. date of transplant ii. tissue and ABO typing iii. B-Cell cross match, PRA iv. Patient/donor EBV and CMV serology
The patients will stay on the same immunosuppression as they were receiving in the STN study, unless medications were changed due to medical reasons. They will be routinely monitored as per center practice.
The drugs are given as standard of care and the extension of this study does not alter the participants' medication regimen.
The following laboratory evaluations are typically performed at each visit.
- Tacrolimus / sirolimus trough concentration. Immunosuppressive regimen will be reviewed and changed or adjusted as necessary.
- CBC with differential
- Chemistry panel: glucose, Na, K, Cl, CO2, Ca, P, Mg, blood urea nitrogen (BUN), albumin and total protein, AST, ALT, bilirubin (total), alkaline phosphatase and serum creatinine 4 Estimated GFR from blood and urine data.
- Fasting lipid profile: total cholesterol, LDL, HDL, HDL/LDL ratio, triglycerides
The following clinical assessments will also be performed and recorded in each visit: 1. Vital signs 2. Weight measurements 3. Concomitant medications 4. Adverse events 5. Opportunistic infections 6. Malignancies 7. Clinical evaluation of signs or symptoms of rejection
Number of patients with adverse events will be summarized by body system and each adverse event. Incidence of adverse events will also be summarized by severity and relationship to study medication. Any serious adverse events or deaths will be summarized separately. patient death, graft loss, the need to be withdrawn from the original assigned calcineurin inhibitor therapy patients who return to dialysis for 6 or more consecutive weeks, patients who experience adverse events that lead to premature withdrawal or loss to follow-up. Patients will be followed until the end of the study in all cases. All failed patients will be followed until the end of the last follow up visit (36 months) unless consent is withdrawn. The proportion of patients experiencing any opportunistic infections will be summarized up to 6, 12, 24 ,and 36 months after randomization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long term Sirolimus or Tacrolimus | – | –Ths study cohort will consist of participants who successfully completed two years of the original Spare the Nephron (STN) study, a two year prospective multi-center study where participants were assigned to receive either center-specific CNI regimen (assigned at the time of transplantation) or were switched to replace the CNI with Sirolimus therapy. In this current long-term follow-up study, we will approach patients who previously enrolled in the STN study and offer them the opportunity to enroll to be followed-up for another 3 years. There will be no change in immunosuppression unless clinically indicated. The majority of effort is standard care with every 6 month follow-up appointments.Participants will be required to consent to participate in the three year extension study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients who were previously enrolled in the Spare-the-nephron study.
Key inclusion criteria (5 listed)
- Male or female post-transplant patients who were in the Spare-the-nephron study.
- Patients capable of understanding the purpose and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
- Women of child bearing potential must not be pregnant or breast-feeding.
- Women of child bearing age must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy or hysterectomy. Effective contraception must be used before beginning of study drug therapy, for duration of study and for 12 weeks following the completion of study.
- Must pass the evaluation to sign informed consent form.
Key exclusion criteria (2 listed)
- Male or female post-transplant patients who were enrolled in the Spare-the-nephron study, however dropped out during the study period.
- Inability to pass the Evaluation to Sign Consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare between treatment groups, change in renal function as measured by 24 hour creatinine clearance and estimated GFR.
Time frame: Every 6 months for 3 years.
1 secondary outcome
Graft and patient survival.
Time frame: Every 6 months for 3 years.
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 May 2022.
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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.
Matthew R Weir, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant, run by University of Maryland, Baltimore 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 5 inclusion and 2 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 May 2022. 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.
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.
What does the primary outcome measure?
To compare between treatment groups, change in renal function as measured by 24 hour creatinine clearance and estimated GFR. (time frame: Every 6 months for 3 years.). 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 2 May 2022.