CSL Vifor Investigator-Initiated Studies

Submitting Requests

Requests can be submitted to phase4@viforpharma.com and must contain the followings:Description of the data requested

Rationale for the proposed research
Statistical Analysis Plan
Publication plan
Qualifications and experience of the research team
Disclosure of any conflicts of interests and competitive use of data
Source of research funding

The CSL Vifor Phase 4 Research Board evaluates the request and, if approved, initiates the process of sharing the requested data with the researcher.

The following represents the areas of research interest for submission of IIS proposals.

Iron Deficiency / Iron Deficiency Anemia

Proposals studying the effects of treating iron deficiency / iron deficiency anemia using any of CSL Vifor ’s iron products should be in-line with the registered, indicated populations.

Intravenous iron products:

Ferric carboxymaltose (Ferinject® / Injectafer®) in iron deficient patients ≥ 14 years of age
Iron sucrose (Venofer®) in iron deficient patients ≥ 3 months of age

Oral iron products:

Iron polymaltose (Maltofer® / Ferrum Hausmann®) in iron deficient patients of any age

Hyperkalemia

IIS proposals in the Hyperkalemia area should aim at investigating the medical need in hyperkalemia or enhancing the medical and scientific knowledge of patiromer, including (but not limited to) investigations into patiromer’s mechanism of action, efficacy and safety, and effects beyond potassium.

Hyperphosphatemia

Investigator-Initiated Study (IIS) proposals in the area of hyperphosphatemia should aim at investigating the clinical and societal benefit of treating hyperphosphatemia with calcium-free, iron-based phosphate binders in CKD patients on dialysis.

Hyperphosphatemia products:

Sucroferric Oxyhydroxide (Velphoro®) is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).