Clinical Trials Logo
  1. Home
  2. Anemia
  3. NCT00317239
  4. Details
NCT00317239 Clinical Trial

VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Anemia Clinical Trial

Official title:
Comparison of Safety & Efficacy of a Unique Intravenous Iron (VIT45) Preparation vs Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00317239
Other study ID # 1VIT04004
Secondary ID
Status Completed
Phase Phase 3
First received April 20, 2006
Last updated January 22, 2018
Start date May 2005
Est. completion date August 2007

Study information
Verified date January 2018
Source Luitpold Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Description:

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Recruitment information / eligibility
Status Completed
Enrollment 255
Est. completion date August 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Males or females > or = 12 years of age

- NDD-CKD subjects

- Baseline hemoglobin < or = 11g/dl

- Stable erythropoietin (EPO) status

Exclusion Criteria:

- Known hypersensitivity to ferrous sulfate or IV iron

- Unstable EPO status

- Anemia not related to CKD

- Chronic, serious infection

- Recent IV iron

- Recent blood transfusion

- Recent blood loss

- Need for surgery

- Received investigational drug within 30 days

- Female subjects who are pregnant or lactating

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ferrous Sulfate tablets
325 mg/TID x 8 weeks
• Ferric Carboxymaltose (FCM)
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.

Locations
Country Name City State
United States Luitpold Pharmaceuticals Norristown Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (3)

Qunibi W, Martinez C, Smith M, Benjamin J, Dinh Q. A Randomized Controlled Trial Comparing IV Ferric Carboxymaltose (FCM) to Oral Iron in Anemic Patients with Non-Dialysis-Dependent CKD. American Society of Nephrology Renal Week 2007.

Qunibi W, Martinez C, Smith M, Benjamin J, Mangione A. A Randomized Controlled Trial Comparing Intravenous Ferric Carboxymaltose to Oral Iron in Anemic Patients with Non-Dialysis-Dependent CKD. American Society of Nephrology Renal Week 2007.

Qunibi WY, Martinez C, Smith M, Benjamin J, Mangione A, Roger SD. A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis-dependent chronic kidney disease patients. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects Achieving an Increase in Hemoglobin =1g/dL anytime during the study
See also
  Status Clinical Trial Phase
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03341338 - Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Completed NCT00060398 - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Phase 3
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Not yet recruiting NCT06309641 - Methemoglobinemia Following Intravenous Iron Treatment
Completed NCT02912494 - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02930850 - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation N/A
Completed NCT03822884 - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers Phase 1
Completed NCT02912533 - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT02384122 - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias Phase 3
Completed NCT02603250 - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda N/A
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Completed NCT02310113 - Transfusion and Skeletal Muscle Tissue Oxygenation N/A
Completed NCT01922479 - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure Phase 4
Withdrawn NCT01934842 - A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate N/A
Completed NCT01693029 - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa Phase 3
Terminated NCT01535781 - Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced? N/A
Completed NCT01458028 - Age and Gender Effects on the Pharmacokinetics of BAY85-3934 Phase 1