Last reviewed · How we verify
NCT04674397: BONES
BOne Dysfunction in Donor NEphrectomieS
trial testing Radioisotope GFR test in Renal Failure in 34 participants. Completed in 1 August 2020.
1 August 2020
Quick facts
| Lead sponsor | Manchester University NHS Foundation Trust |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 34 |
| Start date | 29 July 2015 |
| Primary completion | 1 August 2020 |
| Estimated completion | 1 August 2020 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Radioisotope GFR test
Conditions studied
- Renal Failure — all drugs for Renal Failure →
- Kidney Donors — all drugs for Kidney Donors →
Sponsor
Manchester University NHS Foundation Trust
Who can join
Adults 18 to 80, any sex, with Renal Failure or Kidney Donors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04674397
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Renal Failure
Currently open trials in the same condition.
- NCT07293936 — Post-Filter Hematocrit · NA · recruiting
- NCT06814327 — Assessment of Organ Failure Risk Predictions in ICU · active not recruiting
- NCT06203977 — Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR) · Phase 1 · recruiting
- NCT06142396 — Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure · EARLY_PHASE1 · recruiting
- NCT06620523 — Prevent Cardiac Surgery Associated AKI Trial · Phase 2 · recruiting
Other Manchester University NHS Foundation Trust trials
Trials by the same sponsor.
- NCT07057284 — DENTOFACIAL-PBT Stage 2 - Feasibility Study · enrolling by invitation
- NCT06972238 — Glucose Levels in Acute Pancreatitis and the Impact of Insulin Depletion and Bacterial Endotoxaemia · not yet recruiting
- NCT06681545 — Exploring the Lived Experience of Young Adults With Severe Asthma · recruiting
- NCT07049263 — Disparities In Access to the Northwest Ambulance Service During Pregnancy, Birth and Postpartum Period and Its Associati · active not recruiting
- NCT06561334 — Spasmodic Dysphonia Interviews · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04674397 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Manchester University NHS Foundation Trust
- Last refreshed: 7 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04674397.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing