Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-02 @ 12:36 PM
Study NCT ID:
NCT03301558
Status:
WITHDRAWN
Last Update Posted:
2024-09-19
First Post:
2017-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients
Sponsor:
Prim. Priv. Doz. Dr. Daniel Cejka
Organization:
Study Overview
Official Title:
The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study not started due to organizational reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center, prospective, open-label, randomized, cross-over study.
Detailed Description:
The primary hypothesis (H1) is that the T50 value will change between wash-out and high-dose (3000mg/d) sodium bicarbonate (Nephrotrans®) substitution.
The 0-hypothesis (H0) is that substitution of 3000 mg/d sodium bicarbonate (Nephrotrans®) has no effect on T50-values as compared to wash-out-phase.
Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between.
Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between. The study will start with an initial run-in wash-out phase, where all sodium bicarbonate or other alkalizing treatment taken by the patient as standard of care will be discontinued. Consequently, there will be a sodium bicarbonate treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another sodium bicarbonate treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 ±3 days of duration. Patients will be followed up to 12weeks after randomization until the last study visit of the final wash-out phase.
The 0-hypothesis (H0) is that substitution of 3000 mg/d sodium bicarbonate (Nephrotrans®) has no effect on T50-values as compared to wash-out-phase.
Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between.
Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between. The study will start with an initial run-in wash-out phase, where all sodium bicarbonate or other alkalizing treatment taken by the patient as standard of care will be discontinued. Consequently, there will be a sodium bicarbonate treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another sodium bicarbonate treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 ±3 days of duration. Patients will be followed up to 12weeks after randomization until the last study visit of the final wash-out phase.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: