Sevelamer Carbonate Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several Phase 2 and Phase 3 clinical trials have evaluated sevelamer carbonate for renal conditions, including chronic kidney disease, chronic renal failure, hyperparathyroidism, and chronic hemodialysis. Sponsored by academic medical centers, individual investigators, and pharmaceutical companies such as Genzyme, these studies encompass both completed and terminated trials. Key investigations include a clinical trial evaluating biomarker control in non-dialysis patients and a clinical trial assessing dose-ranging in hyperphosphatemic chronic kidney disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01220843	Completed	Chronic Renal Failure	Centre Hospitalier Universitaire Amiens\|Genzyme a Sanofi Company	2010-10	Phase 3
NCT01191762	Completed	Hyperparathyroidism\|Chronic Kidney Disease	Kenneth R. Phelps M.D.\|Genzyme a Sanofi Company\|Phelps Kenneth R. M.D.	2010-04	Phase 3
NCT01011699	Terminated	Chronic Renal Failure\|Hemodialysis	Centre Hospitalier Universitaire Amiens	2010-01	Phase 3
NCT00853242	Completed	Kidney Failure Chronic	Genzyme a Sanofi Company\|Sanofi	2009-02	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Sevelamer Carbonate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sevelamer carbonate is an orally administered, non-absorbed crosslinked polymer that binds dietary phosphate within the gastrointestinal tract via amine group ion exchange, thereby inhibiting systemic absorption of phosphate and reducing elevated serum phosphorus levels. By preventing hyperphosphatemia and subsequent secondary hyperparathyroidism, this agent effectively reduces pathological calcification and mineral imbalances in patients suffering from chronic renal failure and chronic kidney disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).