Renal FailureBONESNCT04674397
BOne Dysfunction in Donor NEphrectomieS
An observational study of Renal Failure and Kidney Donors, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Most dialysis patients die from vascular disease, which is statistically associated with changes related to chronic kidney disease associated mineral bone disorder (CKD-MBD)3-9. Understanding the mechanisms behind this high death rate is crucial to improving the length and quality of life for patients with all grades… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure, Kidney Donors
- What is being tested?
- Radioisotope GFR test
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jul 2015to 1 Aug 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: living kidney donors
Who may be able to join
- Potential living kidney donors who have completed the medical assessment and have been accepted for kidney donation. -
Who cannot join
- Known to have a significant pathology that may influence markers of renal/bone axis - including but not limited to thyroid disorders, parathyroid disorders, amputees, Paget's disease, and severe osteoporosis.
- Previous treatment with bisphosphonates or denosumab.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M13 9WL
About this study
Official title: Effect of Donor Nephrectomy on Markers of Bone Function in Living Kidney Donors
Most dialysis patients die from vascular disease, which is statistically associated with changes related to chronic kidney disease associated mineral bone disorder (CKD-MBD)3-9. Understanding the mechanisms behind this high death rate is crucial to improving the length and quality of life for patients with all grades of kidney disease, including those on dialysis. This is a priority for patients and clinicians alike.
Most humans with early CKD are asymptomatic and unaware that they have a problem with their kidneys. Therefore they are unlikely to consult a doctor and early CKD is often unrecognised. Patients who are aware of early CKD often have other co-morbidities including diabetes, hypertension and vascular disease which, in the setting of a clinical study, complicate the identification of changes solely resulting from CKD. However over the past decade living kidney donation has become increasingly common and is now the source of organs for more than 120 patients annually at Manchester's renal transplant centre. Prospective donors are carefully examined and known to have normal kidney function without other co-morbidities. They then undergo a planned unilateral nephrectomy and lose approximately 50% of their kidney mass, creating an immediate state of moderate CKD. Over subsequent months the remaining kidney will hypertrophy and partially correct this, although the mechanisms are unknown. In the immediate post-operative period donors are inpatients on the kidney transplant ward and have regular blood and urine tests meaning that careful study of metabolic processes during their recovery is relatively easy by analysis of serial plasma and urine samples. Sequential changes in the plasma and urine levels of different bone turnover markers and metabolites can be analysed and will provide valuable new information to increase our understanding of the initial stage of CKD-MBD development.
Read the detailed description
The likelihood of five year survival for a 60 year old dialysis patient (50%) is significantly worse than for breast (88%), prostate (90%) or colon cancer sufferers (56%)1, but robust information about the contributory risk-factors to inform clinician-patient discussions is lacking2. Most dialysis patients die from vascular disease, which is statistically associated with changes related to chronic kidney disease associated mineral bone disorder (CKD-MBD)3-9. Understanding the mechanisms behind this high death rate is crucial to improving the length and quality of life for patients with all grades of kidney disease, including those on dialysis. This is a priority for patients and clinicians alike.
A recent Kidney Disease Improving Global Outcomes (KDIGO) statement highlighted the poor level of understanding of the mechanisms of CKD-MBD in early and late kidney disease which inhibits the development of targeted therapies to either halt the process or at least improve outcomes10-12.
CKD confers certain atypical risk factors for mortality, most notably a state of disordered mineral metabolism which is implicated in the development of hyperphosphataemia, hyperparathyroidism and vascular calcification. Despite the variety of biological malfunctions attributed to CKD-MBD, the pathophysiology is not understood, partly because there is no animal model of progressive CKD. Rodent models do not survive long enough for the all changes of CKD-MBD to develop. Therefore current therapy is inadequate, and usually deployed late in the course of CKD when the patient has progressed to end-stage renal disease. Furthermore there is no reliable evidence that current therapies improve patient outcome in terms of length or quality of life. The progression of CKD is not always linear and less than 5% of patients proceed to end-stage renal disease. While aetiology of renal impairment determines progression to some extent, there is no reliable means of determining who will progress and who will not so that targeted study of early CKD-MBD pathogenesis is not possible.
Most humans with early CKD are asymptomatic and unaware that they have a problem with their kidneys. Therefore they are unlikely to consult a doctor and early CKD is often unrecognised. Patients who are aware of early CKD often have other co-morbidities including diabetes, hypertension and vascular disease which, in the setting of a clinical study, complicate the identification of changes solely resulting from CKD. However over the past decade living kidney donation has become increasingly common and is now the source of organs for more than 120 patients annually at Manchester's renal transplant centre. Prospective donors are carefully examined and known to have normal kidney function without other co-morbidities. They then undergo a planned unilateral nephrectomy and lose approximately 50% of their kidney mass, creating an immediate state of moderate CKD. Over subsequent months the remaining kidney will hypertrophy and partially correct this, although the mechanisms are unknown. In the immediate post-operative period donors are inpatients on the kidney transplant ward and have regular blood and urine tests meaning that careful study of metabolic processes during their recovery is relatively easy by analysis of serial plasma and urine samples. Sequential changes in the plasma and urine levels of different bone turnover markers and metabolites can be analysed and will provide valuable new information to increase our understanding of the initial stage of CKD-MBD development.
- Conditions
- Renal Failure, Kidney Donors
- Being tested
- Radioisotope GFR test
- Keywords
- Donor, CKD-MBD, FGF23
- Medical subject headings
- Renal Insufficiency, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioisotope GFR testRadiation
| Study group | Role | What they receive |
|---|---|---|
| Test group | Living kidney donors Receives: Radiation: Radioisotope GFR test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in renal volume post-donation
Volume of the remaining kidney is measured by serial MRI scans pre-donation, 4-7 days post-donation and 1 month post donation
Measured: 1 month
Change in kidney function post-donation
isotope GFR is measured 1 month after donation; serum creatinine estimated GFR is measured at pre-donation, 30 minutes, 60 minutes, Day 1,2,3,4 and 7, 2 weeks, 3 weeks, 1 month, 2 months and 3 months after donation; Serum cystatin C estimated GFR is measured at pre-donation, Day 7 and 1 month after donation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start29 Jul 2015
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674397
- Sponsor's protocol ID
- R03728
- Acronym
- BONES
- Status last verified
- Dec 2021
- First submitted
- 16 Mar 2020
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Donor Nephrectomy on Markers of Bone Function in Living Kidney Donors
- ClinicalTrials.gov ID
- NCT04674397
- Acronym / sponsor ID
- BONES / R03728
- Conditions
- Renal Failure, Kidney Donors
- Keywords
- Donor, CKD-MBD, FGF23
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Manchester
- Study start
- 29 Jul 2015 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 19 Dec 2020 (actual)
- 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.
Most dialysis patients die from vascular disease, which is statistically associated with changes related to chronic kidney disease associated mineral bone disorder (CKD-MBD)3-9. Understanding the mechanisms behind this high death rate is crucial to improving the length and quality of life for patients with all grades of kidney disease, including those on dialysis. This is a priority for patients and clinicians alike.
Most humans with early CKD are asymptomatic and unaware that they have a problem with their kidneys. Therefore they are unlikely to consult a doctor and early CKD is often unrecognised. Patients who are aware of early CKD often have other co-morbidities including diabetes, hypertension and vascular disease which, in the setting of a clinical study, complicate the identification of changes solely resulting from CKD. However over the past decade living kidney donation has become increasingly common and is now the source of organs for more than 120 patients annually at Manchester's renal transplant centre. Prospective donors are carefully examined and known to have normal kidney function without other co-morbidities. They then undergo a planned unilateral nephrectomy and lose approximately 50% of their kidney mass, creating an immediate state of moderate CKD. Over subsequent months the remaining kidney will hypertrophy and partially correct this, although the mechanisms are unknown. In the immediate post-operative period donors are inpatients on the kidney transplant ward and have regular blood and urine tests meaning that careful study of metabolic processes during their recovery is relatively easy by analysis of serial plasma and urine samples. Sequential changes in the plasma and urine levels of different bone turnover markers and metabolites can be analysed and will provide valuable new information to increase our understanding of the initial stage of CKD-MBD development.
Detailed description
The likelihood of five year survival for a 60 year old dialysis patient (50%) is significantly worse than for breast (88%), prostate (90%) or colon cancer sufferers (56%)1, but robust information about the contributory risk-factors to inform clinician-patient discussions is lacking2. Most dialysis patients die from vascular disease, which is statistically associated with changes related to chronic kidney disease associated mineral bone disorder (CKD-MBD)3-9. Understanding the mechanisms behind this high death rate is crucial to improving the length and quality of life for patients with all grades of kidney disease, including those on dialysis. This is a priority for patients and clinicians alike.
A recent Kidney Disease Improving Global Outcomes (KDIGO) statement highlighted the poor level of understanding of the mechanisms of CKD-MBD in early and late kidney disease which inhibits the development of targeted therapies to either halt the process or at least improve outcomes10-12.
CKD confers certain atypical risk factors for mortality, most notably a state of disordered mineral metabolism which is implicated in the development of hyperphosphataemia, hyperparathyroidism and vascular calcification. Despite the variety of biological malfunctions attributed to CKD-MBD, the pathophysiology is not understood, partly because there is no animal model of progressive CKD. Rodent models do not survive long enough for the all changes of CKD-MBD to develop. Therefore current therapy is inadequate, and usually deployed late in the course of CKD when the patient has progressed to end-stage renal disease. Furthermore there is no reliable evidence that current therapies improve patient outcome in terms of length or quality of life. The progression of CKD is not always linear and less than 5% of patients proceed to end-stage renal disease. While aetiology of renal impairment determines progression to some extent, there is no reliable means of determining who will progress and who will not so that targeted study of early CKD-MBD pathogenesis is not possible.
Most humans with early CKD are asymptomatic and unaware that they have a problem with their kidneys. Therefore they are unlikely to consult a doctor and early CKD is often unrecognised. Patients who are aware of early CKD often have other co-morbidities including diabetes, hypertension and vascular disease which, in the setting of a clinical study, complicate the identification of changes solely resulting from CKD. However over the past decade living kidney donation has become increasingly common and is now the source of organs for more than 120 patients annually at Manchester's renal transplant centre. Prospective donors are carefully examined and known to have normal kidney function without other co-morbidities. They then undergo a planned unilateral nephrectomy and lose approximately 50% of their kidney mass, creating an immediate state of moderate CKD. Over subsequent months the remaining kidney will hypertrophy and partially correct this, although the mechanisms are unknown. In the immediate post-operative period donors are inpatients on the kidney transplant ward and have regular blood and urine tests meaning that careful study of metabolic processes during their recovery is relatively easy by analysis of serial plasma and urine samples. Sequential changes in the plasma and urine levels of different bone turnover markers and metabolites can be analysed and will provide valuable new information to increase our understanding of the initial stage of CKD-MBD development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | – | Radiation: Radioisotope GFR testLiving kidney donors |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- living kidney donors
Key inclusion criteria (1 listed)
- Potential living kidney donors who have completed the medical assessment and have been accepted for kidney donation. -
Key exclusion criteria (2 listed)
- Known to have a significant pathology that may influence markers of renal/bone axis - including but not limited to thyroid disorders, parathyroid disorders, amputees, Paget's disease, and severe osteoporosis.
- Previous treatment with bisphosphonates or denosumab.
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 |
|---|---|---|
| Radioisotope GFR test | Radiation | Test group |
Primary outcome
Change in renal volume post-donation
Time frame: 1 month
Volume of the remaining kidney is measured by serial MRI scans pre-donation, 4-7 days post-donation and 1 month post donation
Change in kidney function post-donation
Time frame: 3 months
isotope GFR is measured 1 month after donation; serum creatinine estimated GFR is measured at pre-donation, 30 minutes, 60 minutes, Day 1,2,3,4 and 7, 2 weeks, 3 weeks, 1 month, 2 months and 3 months after donation; Serum cystatin C estimated GFR is measured at pre-donation, Day 7 and 1 month after donation.
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 7 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Renal Failure
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
RecruitingPhase 1
Renal Impairment Pharmacokinetics (PK) Trial of Afabicin
Renal Impairment
RecruitingObservational study
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Gastric Antral Vascular Ectasia, Cirrhosis
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?
An observational study of Renal Failure and Kidney Donors, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 1 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 7 Dec 2021. 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 Kingdom. 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?
Change in renal volume post-donation (time frame: 1 month). 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 7 Dec 2021.