Impact of Full Correction of PTA in Renal Transplant Recipients

NCT03861637 | Completed DMC

• 1 other identifier: VDR/JC/81
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Post-transplant anemia (PTA) might be associated cardiovascular morbidity and even increased mortality. Objectives: We aimed to assess the impact of full correction of chronic PTA on cardiovascular system and quality of life in renal transplant recipients with stable graft function using erythropoietin stimulating agents. Patient and methods: We enrolled 247 kidney recipients with stable graft function to be assessed for anemia. Eligible patients were randomized to achieve target hemoglobin between 11 to 12 g/dl (group 1, n=183), or 13 to 15 g/dl (in group 2, n=64) using ESA. Monthly clinical and laboratory evaluation of kidney graft function was carried out. Moreover, quality of life (QOL) and echocardiography were assessed at the start and at 12 months.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• 1 year mortality

  number of deaths during 1st year of the study related to full correction of PTA

  12 months

Study Arms (2)

drug : ESA for p correction of PTA

ACTIVE COMPARATOR

ESA (Aranesp or mir-CERA) injection 1 mg per kg sc every week for 1 year to correct PTA to level between 12-13g/dl.

Other: ESA for correction of PTA to 12-13g/dl

ara or cera

ACTIVE COMPARATOR

ESA (Aranesp) 1mg/ kg (or equivalent doses) of MIR-CERA injection for 1 year to correct PTA to level between 13-15g/dl.

Other: ESA for correction of PTA to 12-13g/dl

Interventions

ESA for correction of PTA to 12-13g/dl OTHER

To assess the impact of full correction of chronic PTA(to near normal values) on cardiovascular system and quality of life in renal transplant recipients with stable graft function using erythropoietin stimulating agents in comparison to partially treated PTA with HB level between 12-13g/dl.

Also known as: ESA for correction of PTA to 13-15g/dl

ara or cera; drug : ESA for p correction of PTA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who fulfilled the following criteria were included in the study:
• Adult renal transplant patients (≥21years),
• Informed consent,
• Stable maintenance subcutaneous ESA therapy with constant dose interval during the last 2 months,
• Haemoglobin (Hb) ≥10mg/dL (Hct 32%),
• Transferrin saturation (TSAT) ≥20% (during the screening phase),
• and serum ferritin ≥100 ng/mL

You may not qualify if:

• We excluded patients with the following criteria:
• Acute or chronic bleeding, or erythrocyte transfusion, within the preceding 8 weeks. change in Hb level ≥ 2 g/dL during screening phase,
• Hemolytic anemia,
• Recent infection or rejection,
• Diastolic blood pressure \>100mmHg or discontinuation of ESA due to hypertension in the 6 months prior to study,
• Vitamin B12 or folic acid deficiency,
• Uncontrolled or secondary hyperparathyroidism,
• Acute or chronic systemic inflammatory disease and/or C-reactive protein (CRP) \>30 mg/L,
• Hemodialysis due to failure of a kidney transplant,
• and malignancy

Sponsors & Collaborators

• Hamid Al-Essa Organ Transplant Center: lead

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: comparison of partially corrected vs. fully corrected PTA in renal transplant recipients

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 4, 2019
• Study Start: January 20, 2015
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: March 4, 2019

Record last verified: 2019-02