Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Blood and Lymph Conditions

Behaviors and Mental Disorders

Colorectal Neoplasms

Adenocarcinoma

Postoperative Complications

Anemia

Hematologic Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Micronutrients

All Drugs and Chemicals

Hematinics

Anti-Infective Agents

Iron

Hepcidins

All recruited patients will be allocated to this treatment. 1 gram of Ferric carboxymaltose (FERINJECT) to be given at recruitment

1 gram intravenous ferric carboxymaltose (FERINJECT) will be administered to all patients within the study

Intravenous ferric carboxymaltose

Austin G Acheson, MD FRCS

20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (FERINJECT).

It is hypothesized that intravenous iron supplementation is efficacious at raising haemoglobin levels and reduced blood transfusion requirements.

Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer.

At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.

This is open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.

All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.

Intravenous Iron: Measuring Response in Anemic Surgical Patients

An Open Label Study of Intravenous Iron (FERINJECT) in Colorectal Adenocarcinoma Related Anaemia to Identify Potential Biomarkers of Responsiveness to Intravenous Iron

To assess the safety and feasibility of the principle of administration of intravenous iron in a single dose, preoperative outpatient visit

To determine if the administration of intravenous iron reduces the number of expected allogenic red blood cell transfusions from recruitment to the perioperative phase

To determine if intravenous iron significantly increases hemoglobin levels in the preoperative optimization of patients

To monitor changes in hepcidin in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in Erythropoietin in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in transferrin saturation levels in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in ferritin levels in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in C Reactive Protein levels over the course of the study, and review if this can predict response to intravenous iron therapy, or is associated with changes in hepcidin

Nottingham University Hospitals NHS Trust

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Renal Insufficiency, Chronic

Renal Insufficiency

Bone Diseases

Vitamin D Deficiency

Bone Diseases, Metabolic

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Bone Density Conservation Agents

Vitamins

Chrysarobin

Vitamin D

Cholecalciferol

Epoetin Alfa

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Target Hemoglobin level: ≥9.5 and \<10.5 g/dL

Target Hemoglobin level: ≥9.5 and \<10.5 g/dL Cholecalciferol: 1,000 IU/day

Target Hemoglobin level: ≥12.5 and \<13.5 g/dL

Target Hemoglobin level: ≥12.5 and \<13.5 g/dL Cholecalciferol: 1,000 IU/day

25 to 250 μg of methoxy polyethylene glycol epoetin beta (Mircera®, Chugai pharmaceutical Co. Ltd.) will be administered subcutaneously at 2- to 6-week interval.

Dose and interval will be adjusted according to hemoglobin level and its target.

High Hb target

1,000 IU (1 tablet)/day, orally. Tablets are repacked into blister package.

cholecalciferol

Takayuki Hamano, MD, PhD

The purpose of this study is to evaluate the effect of anemia correction and vitamin D supplementation in kidney transplant recipients.

Sample size estimation:

The previous trial (the CAPRIT study) showed that 2.0 g/dL increase of hemoglobin (Hb) reduced 69% of 2-year decline in estimated glomerular filtration rate (eGFR) (Choukroun G, et al. J Am Soc Nephrol, 2012). Given that the annual eGFR decline in our patients with Hb level \<10.5 g/dL was 1.66 (SD, 2.47) mL/min per 1.73 m2, the investigators hypothesized that the 2-year eGFR decline in the conservative anemia management group and the aggressive anemia correction group should be 3.32 (SD, 4.94) and 1.03 (SD, 4.94) mL/min per 1.73 m2, respectively. In order to compare the actual efficacy of the intervention with the assumptions above and to evaluate the need for an early termination of the trial, the investigators will perform one interim analysis using a Pocock type α-spending function when a total of 50-60% of the target sample size completed this study or dropped out. Assuming 20% of dropout or lost-to-follow, the planned sample size of 272 patients would yield a power of 90% for group comparison by using t-test with a type I error of 5%.

Regarding cholecalciferol supplementation, 1,000 IU/day would increase serum 25-hydroxyvitamin D level by 11.8 ng/mL in patients with BMI \<30, as suggested by the previous trial (Gallagher JC, et al. Ann Intern Med, 2012). The investigators found in our prospective cohort study that the 98.2% of Japanese kidney transplant recipients had BMI \<30, and that 10 ng/mL increase in 25-hydroxyvitamin D level was significantly associated with 0.75 mL/min/1.73 m2 less decrease in annual eGFR change independent of potential confounders (in submission). As with the anemia intervention arms above, the investigators will perform one interim analysis using a Pocock type α-spending function when a total of 50-60% of the target sample size completed this study or dropped out in order to compare the actual efficacy of the intervention with the assumptions above and to evaluate the need for an early termination of the trial. Therefore, the investigators expect 1.77 mL/min per 1.73 m2 in eGFR would be preserved by 1,000 IU/day of cholecalciferol supplementation for 2 years. Based on this assumption, this study size will provide a power of 70%.

Estimating kidney function:

In primary analyses, eGFR will be calculated by using the Japanese equation as in sample size calculation (Matsuo S, et al. Am J Kidney Dis, 2009). However, this formula has not yet been validated in kidney transplant recipients. Therefore, the investigators will use the creatinine-based CKD-EPI equation with Japanese coefficient (Stevens LA, et al. Nephrol Dial Transplant, 2010. Horio M, et al. Am J Kidney Dis, 2010) and an available formula if validated in Japanese kidney transplant recipients at the time of analysis.

Statistical analyses:

For group comparison in a primary analysis, the investigators will use t-test or Wilcoxon rank sum test according to the distribution of eGFR change. In the further analyses, to analyze the time course of eGFR with respect to treatment assignment, changes in eGFR over time will be analyzed with a linear mixed model for repeated measures with both fixed and random intercept and slope. The multivariate model will contain time-varying eGFR as dependent variable and treatment group as well as the number of measurements (time) as independent variables. The study hypothesis will be tested by adding appropriate interaction terms between the exposures and time. For secondary endpoints, the investigators will use t-test, Wilcoxon rank sum test, or log-rank test for group comparison, and generalized linear models or Cox proportional hazards models to estimate each effect of the interventions, appropriately. The investigators will also adjust for baseline levels or past history of each outcome. Other potential confounders, such as age, sex, time since transplantation, blood pressure, urinary protein level, and diabetes, will be adjusted in sensitivity analyses.

The interaction will be checked between anemia management and cholecalciferol supplementation as well as between each intervention and baseline levels of urinary protein, eGFR, Hb, 25-hydroxyvitamin D, the use of active vitamin D compounds, and the length of time since transplantation. Additionally, stratified analyses will be conducted according to 0.2 g/g･creatinine of urinary protein and the date of transplantation (November 1999, the release date of mycophenolate mofetil in Japan). However, the study size is not large enough to statistically evaluate these interactions. The results from these analyses should be interpreted with caution and regarded as exploratory and hypothesis generating.

Missing values:

Missing values will not be imputed in primary analyses. In sensitivity analyses, the investigators will use multiple imputation method and last-observation-carried-forward method.

Note:

The interim analysis plan was added to the protocol with an increase in the sample size from 246 to 272, which has been approved by the local ethics committee on August 27, 2018.

Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients

A Factorial Randomized Controlled Trial of Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients

For vitamin D supplementation study only.

The adverse composite endpoint consists of death, admission-required cardiovascular diseases, and the renal composite endpoint.

Opportunistic infections includes polyomavirus-associated nephropathy, tuberculosis, Pneumocystis carinii pneumonia, cytomegalovirus infection, herpes zoster, bacterial pneumonia.

For vitamin D supplementation study only.

As allograft kidney function, GFR is estimated by the modified MDRD equation for Japanese patients with chronic kidney disease.

1. protein-creatinine ratio
2. liver type fatty acid binding protein (L-FABP)
3. neutrophil gelatinase-associated lipocalin (NGAL)
4. transforming growth factor (TGF)-β.

1. brain natriuretic peptide (BNP)
2. cardiac troponin-T (cTnT).

1. intact parathyroid hormone (1-84 PTH)
2. bone-type alkaline phosphatase
3. tartrate-resistant acid phosphatase 5b (TRACP-5b)

For vitamin D supplementation study only.

Corrected calcium ≥11 mg/dL

For vitamin D supplementation study only.

renal composite endpoint consists of 50% increase in serum creatinine, subsequent transplantation, and reinitiation of dialysis.

Cardiovascular events includes myocardial infarction, angina, congestive heart failure, stroke, and peripheral artery disease.

Chugai Pharmaceutical

Japanese Society for the Promotion of Science

The Japan Kidney Foundation

Roche Diagnostics GmbH

CANDLE-KIT Trial Study Group

Mineral

Iron Supplement

A minimum of 1 dose of 1000mg of intravenous ferric carboxymaltose will be administered at least 14 days prior to the date of operation.

Ferric carboxymaltose

(Control) 200mg twice a day of oral ferrous sulphate will be administered for a minimum of a two week period

Ferrous Sulphate

Austin G Acheson, MBBS MD FRCS

116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia will be randomized to receive either oral ferrous sulphate (control) or intravenous ferric carboxymaltose (intervention).

It is hypothesized that intravenous iron supplementation is more efficacious than oral iron therapy.

Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer.

At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.

This is a multi-center, randomized, open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. Patients will be randomized to receive intravenous ferric carboxymaltose (treatment group) or oral ferrous sulphate (control). The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles, patient quality of life scores, operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.

The primary hypothesis to be tested is that intravenous iron will decrease transfusion rates. To detect a significant clinical difference in blood transfused consistent with previous published data (1 unit), 58 patients will be required in each arm of the study with 90% power (alpha 0.05).

Randomization will be performed independently to the trial team using a computer generated variable block randomization program.

All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.

IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia

An Open Label Study to Determine the Efficacy of Ferric Carboxymaltose in Preoperative Colorectal Cancer Related Anaemia, and to Develop Biomarkers to Predict Response to This Treatment Strategy

To investigate if the number of units transfused per participant, the number of participants whom receive a blood transfusion and the total number of units of blood transfused differs between the two study arms. This period monitored will begin at enrolment into the study, and cease at review in outpatient clinic 6 - 12 weeks post operatively.

Hematinic markers include ferritin, iron, transferrin, transferrin saturation, erythropoietin.

To review the use of hepcidin as a biomarker to predict response to therapy.

Iron transport proteins include DMT TFR1, Ferroportin, Ferritin. As acquired from examination of pathology tissue specimen excised.

Post-operative outcomes include morbidity, mortality, length of stay.

Quality of Life questionnaires will be used (SF-36\[short form 36\] and EQ-5D)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravenous Iron: Measuring Response in Anemic Surgical Patients	NCT02057471	Colorectal Neop... Anemia	Intravenous fer...	18 Years -	Nottingham University Hospitals NHS Trust
Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients	NCT01817699	Kidney Transpla... Anemia Vitamin D Defic... Renal Insuffici...	High Hb target cholecalciferol	20 Years - 79 Years	CANDLE-KIT Trial Study Group
IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia	NCT01701310	Anemia Colorectal Neop...	Ferric carboxym... Ferrous Sulphat...	18 Years -	Nottingham University Hospitals NHS Trust
Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients	NCT01817699	Kidney Transpla... Anemia Vitamin D Defic... Renal Insuffici...	High Hb target cholecalciferol	20 Years - 79 Years	CANDLE-KIT Trial Study Group
Intravenous Iron: Measuring Response in Anemic Surgical Patients	NCT02057471	Colorectal Neop... Anemia	Intravenous fer...	18 Years -	Nottingham University Hospitals NHS Trust

Spots Global Cancer Trial Database for hematinics

Every month we try and update this database with for hematinics cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hematinics

Every month we try and update this database with for hematinics cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hematinics cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.