Clinical Trials

Several clinical trials spanning Phase 2 and Phase 3 evaluate sevelamer formulations for managing metabolic complications of renal disease, including chronic renal failure, chronic kidney disease, secondary hyperparathyroidism, and hemodialysis-associated renal failure. Sponsored by industry entities like Genzyme (a Sanofi company) alongside academic institutions such as Centre Hospitalier Universitaire Amiens, this research assesses phosphatemia regulation and associated pathological markers. While the majority of these registered studies have been completed, a clinical trial was terminated prior to completion.

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 HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sevelamer hydrochloride is a non-absorbed polymeric amine binder that directly sequesters dietary phosphate within the gastrointestinal lumen through ionic interactions. By preventing intestinal absorption of phosphate and reducing circulating phosphorus levels, this action effectively controls hyperphosphatemia and mitigates secondary hyperparathyroidism in patients with 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>).

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Note: Technical data last updated: Sep 1, 2026.