Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients

NCT01894906 | Completed Phase 1 Results

• 1 other identifier: RMTI-SFP-8
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the quantity of iron derived from SFP that is transferred from the dialysate to patients during a single dialysis session. The effects of various conditions which may affect the transfer of iron such as blood and dialysate flow rate, changes in bicarbonate delivery, dialyzer membrane type and the effect of reuse will also be investigated. The absorption and removal of iron from the blood will also be investigated.

Conditions

Kidney Failure

Keywords

Soluble Ferric Pyrophosphate,; Pharmacokinetics,; Iron, Mass Transfer,; Hemodialysis; chronic therapy;

Outcome Measures

Primary Outcomes (1)

• Net Iron Delivery From SFP Via the Dialysate

  To measure the SFP-derived total iron from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate). Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.

  one dialysis session (approximately 4 hours)

Secondary Outcomes (4)

• To Compare the Amount of SFP-derived Iron Administered Under Various Treatment Conditions to the Reference HD

  one dialysis session (approximately 4 hours)

• Pharmacokinetics of Serum Iron and Exploratory Modeling

  one dialysis session (approximately 4 hours)

• Dialysate InFlow Iron Concentration

  4 hours

• Dialysate OutFlow Iron Concentration

  4 hours

Study Arms (2)

Control

PLACEBO COMPARATOR

Each subject will receive one control treatment and 5 treatments with SFP added to dialysate. The 5 SFP treatments will encompass 5 different conditions which may impact the intradialytic transfer of iron to the subject: new dialyzer, reused dialyzer, low blood/dialysate flow rate, low machine delivered bicarbonate concentration, and a different synthetic dialysis membrane (PAES).

Other: Placebo

Soluble Ferric Pyrophosphate

EXPERIMENTAL

Group/ cohort designation: Cellulose dialysis membrane (CT-190)/ Polyamide membrane. Each subject will receive one control treatment and 5 treatments with SFP added to dialysate. The 5 SFP treatments will encompass 5 different conditions which may impact the intradialytic transfer of iron to the subject: new dialyzer, reused dialyzer, low blood/dialysate flow rate, low machine delivered bicarbonate concentration, and a different synthetic dialysis membrane (PAES).

Drug: Soluble Ferric Pyrophosphate

Interventions

Soluble Ferric Pyrophosphate DRUG

Also known as: SFP

Soluble Ferric Pyrophosphate

Placebo OTHER

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subject ≥ 18 years of age undergoing chronic hemodialysis for chronic kidney disease (CKD) for at least 3 months, expected to remain on hemodialysis and be able to complete the study.
• Screening Hgb ≥ 9.5 g/dL.
• Screening transferrin saturation % (TSAT) ≥ 15% to ≤ 45%.
• Screening serum ferritin ≥ 200 to ≤ 1200 µg/L.
• Subject's standard dialyzer membrane is one of the 2 types, i.e. Baxter CT-190 or Gambro 17R or 21R.
• The subject uses a reprocessed dialyzer for standard HD treatments.
• Prescribed dialysis 3X/week.
• Minimally adequate measured dialysis dose defined as URR (urea reduction ratio) ≥ 65%, or single-pool Kt/V (dialyzer clearance of urea multiplied by dialysis time, divided by patient's total body water) ≥ 1.2, or KIDt/V (online dialyzer clearance measured using ionic dialysance multiplied by dialysis time, divided by patients total body water) ≥ 1.2.
• Stable dialyzer blood flow rate that is generally ≥ 350 mL/min and acceptable to the Investigator.
• Stable dialysate flow rate that is generally ≥ 600 mL/min and acceptable to the Investigator.
• Vascular access for dialysis that will be used upon enrollment with stable function in the judgment of the Investigator.
• Female subjects must be either amenorrheic for ≥ 1 year or agree to not become pregnant by continuous use of an effective birth control method acceptable to the Investigator for the duration of their participation in the study.
• Must be willing and able to provide written informed consent directly or through their authorized representative.

You may not qualify if:

• Subject has a living kidney donor identified or living-donor kidney transplant scheduled during study participation. (Note: Patients awaiting deceased-donor transplant need not be excluded.)
• Vascular access for hemodialysis is a femoral catheter.
• Known active bleeding from any site other than AV fistula or graft (e.g., gastrointestinal, hemorrhoidal, nasal, pulmonary, etc.).
• Scheduled surgery during the study.
• RBC or whole blood transfusion within 4 weeks prior to Screening.
• Hospitalization in the month prior to Screening (except for vascular access surgery) that, in the opinion of the Investigator, confers a significant risk of hospitalization during the course of this study.
• Evidence of current malignancy involving a site other than skin (except any melanoma, which renders the patient non-eligible).
• History of drug or alcohol abuse within the last 6 months.
• Regularly requiring hemodialysis more than three times per week.
• Noncompliance with dialysis regimen in the opinion of the Investigator.
• Pregnancy or intention to become pregnant before completing all study drug treatment.
• Known ongoing inflammatory disorder (other than CKD), such as systemic lupus erythematosus, rheumatoid arthritis, or other collagen-vascular disease undergoing a disease flare.
• Any current febrile illness (e.g., oral temperature \> 100.4°F, 38°C). (The patient may subsequently become eligible at least 1 week after resolution of the illness).
• Known active bacterial, tuberculosis, fungal, viral, or parasitic infection requiring anti-microbial therapy or anticipated to require anti-microbial therapy during the patient's participation in this study.
• Occult tuberculosis requiring prophylactic treatment with anti-tubercular drug(s) that overlaps with the patient's participation in this study.

Sponsors & Collaborators

• Rockwell Medical Technologies, Inc.: lead

Study Sites (1)

Unknown Facility

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

spleen fibrinolytic proteinase (human)

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Total iron, TBI, NTBI, and UIBC could not be measured because the ferrozine assay for total iron and transferrin-bound iron was unreliable due to the presence of heparin in the samples, which caused the formation of fibrin strands.

Results Point of Contact

• Title: Senior Director, Clinical Research & Operations
• Organization: Rockwell Medical

rd@rockwellmed.com

248-960-9009

Study Officials

• Raymond D Pratt, MC FACP

  Rockwell Medical Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 10, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 16, 2015
• Results First Posted: January 9, 2015

Record last verified: 2015-01

Locations

US (1)